Refractory Chronic Cough
Conditions
Brief summary
This study is designed to evaluate the efficacy of three dose regimens of gefapixant (\[MK-7264\] 7.5 mg, 20 mg, and 50 mg) relative to placebo in reducing awake objective cough frequency. The primary hypothesis for this trial is that at least one dose regimen of gefapixant is superior to placebo with respect to the mean change from baseline in awake cough frequency (on the log scale).
Interventions
DRUGGefapixant
Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.
Sponsors
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women and Men between 18 and 80 years of age inclusive * Have refractory chronic cough * Women of child-bearing potential must use 2 forms of acceptable birth control - Have provided written informed consent. * Are willing and able to comply with all aspects of the protocol
Exclusion criteria
* Current smoker * Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio \<60% * History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit * History of opioid use within 1 week of the Baseline Visit * Body mass index (BMI) \<18 kg/m\^2 or ≥ 40 kg/m\^2 * History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with \<3 excised basal cell carcinomas) * Screening systolic blood pressure (SBP) \>160 mm Hg or a diastolic blood pressure (DBP) \>90 mm Hg * Clinically significant abnormal electrocardiogram (ECG) at Screening * Significantly abnormal laboratory tests at Screening * Pregnant or Breastfeeding * Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participant inappropriate for entry into this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | Baseline Visit (Day -1), Day 84 | Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. Least-squares (LS) mean change from baseline (in log scale) with associated standard error (SE) reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | Baseline (Study Day -1), Day 56 | 24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency). |
| Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | Baseline (Study Day -1), Day 84 | 24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency). |
| Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | Baseline (Study Day -1), Day 28, | Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency). |
| Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | Baseline (Study Day -1), Day 56 | Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency). |
| Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | Baseline (Study Day -1), Day 98 | Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at the Follow-up visit (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency). |
| Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After 4 Weeks of Treatment (Day 28) | Baseline (Study Day -1), Day 28 | Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 4 (Day 28). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group. |
| Change From Baseline in Cough Severity VAS After 8 Weeks of Treatment (Day 56) | Baseline (Study Day -1), Day 56 | Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 8 (Day 56). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group. |
| Change From Baseline in Cough Severity VAS After 12 Weeks of Treatment (Day 84) | Baseline (Study Day -1), Day 84 | Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 12 (Day 84). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group. |
| Change From Baseline in Cough Severity VAS At Day 85/Early Termination | Baseline (Study Day -1), Day 85 | Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Day 85/Early Termination. Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group. |
| Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | Baseline (Study Day -1), Day 28 | Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 28. |
| Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | Baseline (Study Day -1), Day 56 | Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 56. |
| Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | Baseline (Study Day -1), Day 84 | Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 84. |
| Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | Baseline (Study Day -1), Day 98 | Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at the Follow-up visit (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 98. |
| Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | Baseline (Study Day -1), Day 28 | 24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 28. |
| Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | Baseline (Study Day -1), Day 56 | 24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 56. |
| Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | Baseline (Study Day -1), Day 84 | 24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 84. |
| Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | Baseline (Study Day -1), Day 98 | 24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 14 (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 98. |
| Change From Baseline in Sleep Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | Baseline (Study Day -1), Day 28 | Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency). |
| Change From Baseline in Sleep Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | Baseline (Study Day -1), Day 56 | Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency). |
| Change From Baseline in Sleep Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | Baseline (Study Day -1), Day 84 | Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency). |
| Change From Baseline in Weekly Mean Daily Cough Severity Diary (CSD) Total Score at Week 1 | Baseline, Week 1 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 2 | Baseline, Week 2 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 3 | Baseline, Week 3 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 4 | Baseline, Week 4 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 5 | Baseline, Week 5 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 6 | Baseline, Week 6 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 7 | Baseline, Week 7 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 8 | Baseline, Week 8 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 9 | Baseline, Week 9 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 10 | Baseline, Week 10 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 11 | Baseline, Week 11 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily CSD Total Score at Week 12 | Baseline, Week 12 | The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1). |
| Change From Baseline in Weekly Mean Daily Cough Score (DCS) at Week 1 | Baseline, Week 1 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 2 | Baseline, Week 2 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 3 | Baseline, Week 3 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 4 | Baseline, Week 4 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 5 | Baseline, Week 5 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 6 | Baseline, Week 6 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 7 | Baseline, Week 7 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 8 | Baseline, Week 8 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 9 | Baseline, Week 9 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 10 | Baseline, Week 10 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 11 | Baseline, Week 11 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Weekly Mean DCS at Week 12 | Baseline, Week 12 | The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group. |
| Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 28) | Baseline, Day 28 | The LCQ instrument is designed to assess the impact of cough on various aspects of a participant's life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE. |
| Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 8 Weeks of Treatment (Day 56) | Baseline, Day 56 | The LCQ instrument is designed to assess the impact of cough on various aspects of a participant's life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE. |
| Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score At Day 85/Early Termination | Baseline, Day 85/Early Termination | The LCQ instrument is designed to assess the impact of cough on various aspects of a participant's life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE. |
| Percentage of Participants Reporting Very Much Improved or Much Improved According to the Patient's Global Impression of Change (PGIC) After 4 Weeks of Treatment (Day 28) | Day 28 | The self-reported measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the participant's global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group. |
| Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC After 8 Weeks of Treatment (Day 56) | Day 56 | The self-reported measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the participant's global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group. |
| Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC at Day 85/Early Termination | Day 85/Early Termination | The self-reported measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the participant's global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group. |
| Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | Baseline (Study Day -1), Day 28 | 24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency). |
| Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Day 85/Early Termination | At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of At least one year. The counts and percentages of ordered categorical responses to this question were computed for each treatment group. |
| Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Day 85/Early Termination | At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of At least six months. The counts and percentages of ordered categorical responses to this question were computed for each treatment group. |
| Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Day 85/Early Termination | At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of At least four weeks. The counts and percentages of ordered categorical responses to this question were computed for each treatment group. |
| Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Day 85/Early Termination | At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of Twice daily. The counts and percentages of ordered categorical responses to this question were computed for each treatment group. |
| Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Day 84 | The tolerance to taste-related adverse events (AEs) was evaluated at the end of the study (Day 84) and a structured taste questionnaire was administered to participants experiencing a taste-related AE. Participants were asked to indicate the frequency that they experienced the taste effect by answering the question How frequently do you experience the taste effect after taking each dose of medication? The counts and percentages of categorical frequency responses to the individual items were computed for each treatment group. |
| Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Day 84 | The tolerance to taste-related adverse events (AEs) was evaluated at the end of the study (Day 84) and a structured taste questionnaire was administered to participants experiencing a taste-related AE to determine what degree the participant found the taste effect bothersome by answering the question How bothersome is the taste effect of the medication? The counts and percentages of categorical responses to the individual items were computed for each treatment group. |
| Percentage of Participants Rated as Very Much Improved or Much Improved by Clinicians According to the Clinician's Global Impression of Change (CGIC) at Day 85/Early Termination | Day 85/Early Termination | The Clinician's Global Impression of Change (CGIC) reflects a clinician's belief about the efficacy of treatment. CGIC is a 7-point scale depicting a clinician's rating of a participant's overall improvement. Clinicians rated the participant's change at Week 12 (Day 85) as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the clinician's global perception of change were computed for each treatment group, and the percentage of participants rated by clinicians as having improvement (either very much improved or much improved on the CGIC scale) was reported for each treatment group. |
Participant flow
Pre-assignment details
Of 367 screened, 253 were randomized to treatment with placebo or 7.5 mg, 20 mg, or 50 mg gefapixant. One participant randomized to receive 7.5 mg gefapixant was discontinued before receiving treatment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks. | 63 |
| Gefapixant 7.5 mg Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks. | 64 |
| Gefapixant 20 mg Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks. | 63 |
| Gefapixant 50 mg Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks. | 63 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 3 | 10 |
| Overall Study | Cough Improvement | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Noncompliance | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | Gefapixant 7.5 mg | Gefapixant 20 mg | Gefapixant 50 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 10.9 | 59.9 years STANDARD_DEVIATION 10.46 | 61.8 years STANDARD_DEVIATION 9.13 | 59.3 years STANDARD_DEVIATION 9.19 | 60.2 years STANDARD_DEVIATION 9.94 |
| Sex: Female, Male Female | 47 Participants | 48 Participants | 48 Participants | 50 Participants | 193 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 15 Participants | 13 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 63 | 26 / 63 | 45 / 63 | 52 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 | 0 / 63 | 1 / 63 |
Outcome results
Primary
Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84)
Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. Least-squares (LS) mean change from baseline (in log scale) with associated standard error (SE) reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).
Time frame: Baseline Visit (Day -1), Day 84
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline primary endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.40 log coughs/hour | Standard Error 0.11 |
| Gefapixant 7.5 mg | Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.64 log coughs/hour | Standard Error 0.11 |
| Gefapixant 20 mg | Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.65 log coughs/hour | Standard Error 0.11 |
| Gefapixant 50 mg | Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.86 log coughs/hour | Standard Error 0.11 |
Comparison: Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% confidence intervals (CIs) were estimated using a mixed effect repeated measures (MMRM) model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.097195% CI: [-0.54, 0.05]Mixed Effect Repeated Measures model
Comparison: Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.092895% CI: [-0.54, 0.04]Mixed Effect Repeated Measures model
Comparison: Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.002795% CI: [-0.76, -0.16]Mixed Effect Repeated Measures model
Secondary
Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks
At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of At least four weeks. The counts and percentages of ordered categorical responses to this question were computed for each treatment group.
Time frame: Day 85/Early Termination
Population: All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the four week question at Day 85.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Likely | 18.3 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Unlikely | 1.7 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Extremely likely | 73.3 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Neither likely or unlikely | 3.3 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Extremely unlikely | 3.3 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Neither likely or unlikely | 1.7 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Likely | 19.0 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Extremely likely | 72.4 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Unlikely | 1.7 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Extremely unlikely | 5.2 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Neither likely or unlikely | 6.9 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Extremely unlikely | 5.2 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Unlikely | 1.7 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Likely | 15.5 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Extremely likely | 70.7 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Likely | 26.3 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Unlikely | 5.3 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Extremely unlikely | 0.0 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Neither likely or unlikely | 8.8 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks | Extremely likely | 59.6 percentage of participants |
Comparison: 4 Week Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.7559Cochran-Mantel-Haenszel
Comparison: 4 Week Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.5091Cochran-Mantel-Haenszel
Comparison: 4 Week Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.279Cochran-Mantel-Haenszel
Secondary
Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year
At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of At least one year. The counts and percentages of ordered categorical responses to this question were computed for each treatment group.
Time frame: Day 85/Early Termination
Population: All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the one year question at Day 85.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Likely | 30.0 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Unlikely | 3.3 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Extremely likely | 58.3 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Neither likely or unlikely | 5.0 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Extremely unlikely | 3.3 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Neither likely or unlikely | 5.2 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Likely | 15.5 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Extremely likely | 70.7 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Unlikely | 1.7 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Extremely unlikely | 6.9 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Neither likely or unlikely | 12.1 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Extremely unlikely | 5.2 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Unlikely | 3.4 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Likely | 13.8 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Extremely likely | 65.5 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Likely | 29.8 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Unlikely | 12.3 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Extremely unlikely | 1.8 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Neither likely or unlikely | 1.8 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year | Extremely likely | 54.4 percentage of participants |
Comparison: 1 Year Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for the gefapixant vs. placebo using CMH test.p-value: 0.8464Cochran-Mantel-Haenszel
Comparison: 1 Year Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.7687Cochran-Mantel-Haenszel
Comparison: 1 Year Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.4364Cochran-Mantel-Haenszel
Secondary
Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months
At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of At least six months. The counts and percentages of ordered categorical responses to this question were computed for each treatment group.
Time frame: Day 85/Early Termination
Population: All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the six month question at Day 85.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Likely | 21.7 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Unlikely | 1.7 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Extremely likely | 66.7 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Neither likely or unlikely | 6.7 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Extremely unlikely | 3.3 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Neither likely or unlikely | 3.5 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Likely | 14.0 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Extremely likely | 73.7 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Unlikely | 3.5 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Extremely unlikely | 5.3 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Neither likely or unlikely | 6.9 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Extremely unlikely | 5.2 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Unlikely | 3.4 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Likely | 17.2 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Extremely likely | 67.2 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Likely | 29.8 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Unlikely | 10.5 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Extremely unlikely | 1.8 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Neither likely or unlikely | 3.5 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months | Extremely likely | 54.4 percentage of participants |
Comparison: 6 Month Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.9966Cochran-Mantel-Haenszel
Comparison: 6 Month Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.6372Cochran-Mantel-Haenszel
Comparison: 6 Month Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.2155Cochran-Mantel-Haenszel
Secondary
Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily
At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of Twice daily. The counts and percentages of ordered categorical responses to this question were computed for each treatment group.
Time frame: Day 85/Early Termination
Population: All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the twice daily question at Day 85.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Likely | 20.0 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Unlikely | 0.0 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Extremely likely | 73.3 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Neither likely or unlikely | 3.3 percentage of participants |
| Placebo | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Extremely unlikely | 3.3 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Neither likely or unlikely | 5.3 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Likely | 15.8 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Extremely likely | 71.9 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Unlikely | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Extremely unlikely | 7.0 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Neither likely or unlikely | 3.5 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Extremely unlikely | 5.3 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Unlikely | 3.5 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Likely | 22.8 percentage of participants |
| Gefapixant 20 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Extremely likely | 64.9 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Likely | 30.4 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Unlikely | 5.4 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Extremely unlikely | 1.8 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Neither likely or unlikely | 8.9 percentage of participants |
| Gefapixant 50 mg | Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily | Extremely likely | 53.6 percentage of participants |
Comparison: Twice Daily Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.3887Cochran-Mantel-Haenszel
Comparison: Twice Daily Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.2333Cochran-Mantel-Haenszel
Comparison: Twice Daily Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.0534Cochran-Mantel-Haenszel
Secondary
Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84)
24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency).
Time frame: Baseline (Study Day -1), Day 84
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.39 log coughs/hour | Standard Error 0.1 |
| Gefapixant 7.5 mg | Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.62 log coughs/hour | Standard Error 0.1 |
| Gefapixant 20 mg | Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.64 log coughs/hour | Standard Error 0.1 |
| Gefapixant 50 mg | Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.86 log coughs/hour | Standard Error 0.11 |
Comparison: Day 84 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.099195% CI: [-0.52, 0.04]Mixed Effect Repeated Measures model
Comparison: Day 84 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.081195% CI: [-0.53, 0.03]Mixed Effect Repeated Measures model
Comparison: Day 84 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.001495% CI: [-0.76, -0.19]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28)
24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency).
Time frame: Baseline (Study Day -1), Day 28
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.41 log coughs/hour | Standard Error 0.1 |
| Gefapixant 7.5 mg | Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.59 log coughs/hour | Standard Error 0.1 |
| Gefapixant 20 mg | Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.46 log coughs/hour | Standard Error 0.1 |
| Gefapixant 50 mg | Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.93 log coughs/hour | Standard Error 0.1 |
Comparison: Day 28 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.191495% CI: [-0.47, 0.09]Mixed Effect Repeated Measures model
Comparison: Day 28 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.709995% CI: [-0.33, 0.23]Mixed Effect Repeated Measures model
Comparison: Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.000395% CI: [-0.8, -0.24]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56)
24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency).
Time frame: Baseline (Study Day -1), Day 56
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.31 log coughs/hour | Standard Error 0.11 |
| Gefapixant 7.5 mg | Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.71 log coughs/hour | Standard Error 0.11 |
| Gefapixant 20 mg | Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.59 log coughs/hour | Standard Error 0.11 |
| Gefapixant 50 mg | Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.93 log coughs/hour | Standard Error 0.11 |
Comparison: Day 56 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.009995% CI: [-0.71, -0.1]Mixed Effect Repeated Measures model
Comparison: Day 56 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.069595% CI: [-0.58, 0.02]Mixed Effect Repeated Measures model
Comparison: Day 56 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.000195% CI: [-0.93, -0.31]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28)
Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).
Time frame: Baseline (Study Day -1), Day 28,
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.41 log coughs/hour | Standard Error 0.1 |
| Gefapixant 7.5 mg | Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.62 log coughs/hour | Standard Error 0.1 |
| Gefapixant 20 mg | Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.48 log coughs/hour | Standard Error 0.1 |
| Gefapixant 50 mg | Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.90 log coughs/hour | Standard Error 0.11 |
Comparison: Day 28 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate. .p-value: 0.146895% CI: [-0.5, 0.07]Mixed Effect Repeated Measures model
Comparison: Day 28 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.587495% CI: [-0.36, 0.2]Mixed Effect Repeated Measures model
Comparison: Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.000895% CI: [-0.78, -0.21]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56)
Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).
Time frame: Baseline (Study Day -1), Day 56
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.31 log coughs/hour | Standard Error 0.11 |
| Gefapixant 7.5 mg | Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.70 log coughs/hour | Standard Error 0.12 |
| Gefapixant 20 mg | Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.63 log coughs/hour | Standard Error 0.11 |
| Gefapixant 50 mg | Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.90 log coughs/hour | Standard Error 0.12 |
Comparison: Day 56 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.017795% CI: [-0.7, -0.07]Mixed Effect Repeated Measures model
Comparison: Day 56 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.049895% CI: [-0.63, 0]Mixed Effect Repeated Measures model
Comparison: Day 56 Awake Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.000495% CI: [-0.92, -0.27]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98)
Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at the Follow-up visit (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).
Time frame: Baseline (Study Day -1), Day 98
Population: All randomized participants who had taken at least 1 dose of study medication and provided baseline and follow-up visit (Day 98) data during the treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | -6.4 coughs/hour | Standard Deviation 22.72 |
| Gefapixant 7.5 mg | Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | -9.3 coughs/hour | Standard Deviation 47.72 |
| Gefapixant 20 mg | Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | -7.4 coughs/hour | Standard Deviation 29.24 |
| Gefapixant 50 mg | Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | -16.2 coughs/hour | Standard Deviation 39 |
Secondary
Change From Baseline in Cough Severity VAS After 12 Weeks of Treatment (Day 84)
Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 12 (Day 84). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.
Time frame: Baseline (Study Day -1), Day 84
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cough Severity VAS After 12 Weeks of Treatment (Day 84) | -16.7 units on a scale | Standard Error 3.04 |
| Gefapixant 7.5 mg | Change From Baseline in Cough Severity VAS After 12 Weeks of Treatment (Day 84) | -21.1 units on a scale | Standard Error 3.08 |
| Gefapixant 20 mg | Change From Baseline in Cough Severity VAS After 12 Weeks of Treatment (Day 84) | -23.1 units on a scale | Standard Error 3.05 |
| Gefapixant 50 mg | Change From Baseline in Cough Severity VAS After 12 Weeks of Treatment (Day 84) | -27.9 units on a scale | Standard Error 3.16 |
Comparison: Day 84 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.30295% CI: [-12.9, 4]Mixed Effect Repeated Measures model
Comparison: Day 84 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.136595% CI: [-14.8, 2]Mixed Effect Repeated Measures model
Comparison: Day 84 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.010895% CI: [-19.7, -2.6]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Cough Severity VAS After 8 Weeks of Treatment (Day 56)
Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 8 (Day 56). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.
Time frame: Baseline (Study Day -1), Day 56
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cough Severity VAS After 8 Weeks of Treatment (Day 56) | -16.1 units on a scale | Standard Error 3.18 |
| Gefapixant 7.5 mg | Change From Baseline in Cough Severity VAS After 8 Weeks of Treatment (Day 56) | -18.8 units on a scale | Standard Error 3.19 |
| Gefapixant 20 mg | Change From Baseline in Cough Severity VAS After 8 Weeks of Treatment (Day 56) | -19.4 units on a scale | Standard Error 3.18 |
| Gefapixant 50 mg | Change From Baseline in Cough Severity VAS After 8 Weeks of Treatment (Day 56) | -26.9 units on a scale | Standard Error 3.33 |
Comparison: Day 56 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.55495% CI: [-11.5, 6.2]Mixed Effect Repeated Measures model
Comparison: Day 56 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.470295% CI: [-12, 5.6]Mixed Effect Repeated Measures model
Comparison: Day 56 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.019795% CI: [-19.8, -1.7]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Cough Severity VAS At Day 85/Early Termination
Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Day 85/Early Termination. Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.
Time frame: Baseline (Study Day -1), Day 85
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cough Severity VAS At Day 85/Early Termination | -15.2 units on a scale | Standard Error 3 |
| Gefapixant 7.5 mg | Change From Baseline in Cough Severity VAS At Day 85/Early Termination | -19.2 units on a scale | Standard Error 3.04 |
| Gefapixant 20 mg | Change From Baseline in Cough Severity VAS At Day 85/Early Termination | -23.4 units on a scale | Standard Error 3.03 |
| Gefapixant 50 mg | Change From Baseline in Cough Severity VAS At Day 85/Early Termination | -31.1 units on a scale | Standard Error 3.09 |
Comparison: Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.350995% CI: [-12.3, 4.4]Mixed Effect Repeated Measures model
Comparison: Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.051995% CI: [-16.6, 0.1]Mixed Effect Repeated Measures model
Comparison: Day 85/Early Termination Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.000395% CI: [-24.3, -7.5]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After 4 Weeks of Treatment (Day 28)
Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 4 (Day 28). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.
Time frame: Baseline (Study Day -1), Day 28
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After 4 Weeks of Treatment (Day 28) | -15.2 units on a scale | Standard Error 3.02 |
| Gefapixant 7.5 mg | Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After 4 Weeks of Treatment (Day 28) | -21.6 units on a scale | Standard Error 3.05 |
| Gefapixant 20 mg | Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After 4 Weeks of Treatment (Day 28) | -18.1 units on a scale | Standard Error 3.04 |
| Gefapixant 50 mg | Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After 4 Weeks of Treatment (Day 28) | -25. units on a scale | Standard Error 3.09 |
Comparison: Day 28 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.131895% CI: [-14.8, 1.9]Mixed Effect Repeated Measures model
Comparison: Day 28 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.491795% CI: [-11.3, 5.4]Mixed Effect Repeated Measures model
Comparison: Day 28 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.022895% CI: [-18.2, -1.4]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 28)
The LCQ instrument is designed to assess the impact of cough on various aspects of a participant's life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE.
Time frame: Baseline, Day 28
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 28) | 2.1 score on a scale | Standard Error 0.4 |
| Gefapixant 7.5 mg | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 28) | 2.9 score on a scale | Standard Error 0.4 |
| Gefapixant 20 mg | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 28) | 2.3 score on a scale | Standard Error 0.4 |
| Gefapixant 50 mg | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 28) | 4.2 score on a scale | Standard Error 0.4 |
Comparison: Day 28 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.16395% CI: [-0.3, 1.9]Mixed Effect Repeated Measures model
Comparison: Day 28 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.760195% CI: [-1, 1.3]Mixed Effect Repeated Measures model
Comparison: Day 28 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.000495% CI: [0.9, 3.2]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 8 Weeks of Treatment (Day 56)
The LCQ instrument is designed to assess the impact of cough on various aspects of a participant's life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE.
Time frame: Baseline, Day 56
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 8 Weeks of Treatment (Day 56) | 2.0 score on a scale | Standard Error 0.4 |
| Gefapixant 7.5 mg | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 8 Weeks of Treatment (Day 56) | 3.1 score on a scale | Standard Error 0.4 |
| Gefapixant 20 mg | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 8 Weeks of Treatment (Day 56) | 3.0 score on a scale | Standard Error 0.4 |
| Gefapixant 50 mg | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 8 Weeks of Treatment (Day 56) | 3.5 score on a scale | Standard Error 0.5 |
Comparison: Day 56 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.094195% CI: [-0.2, 2.3]Mixed Effect Repeated Measures model
Comparison: Day 56 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.132195% CI: [-0.3, 2.2]Mixed Effect Repeated Measures model
Comparison: Day 56 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.019295% CI: [0.2, 2.7]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score At Day 85/Early Termination
The LCQ instrument is designed to assess the impact of cough on various aspects of a participant's life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE.
Time frame: Baseline, Day 85/Early Termination
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score At Day 85/Early Termination | 2.1 score on a scale | Standard Error 0.4 |
| Gefapixant 7.5 mg | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score At Day 85/Early Termination | 3.3 score on a scale | Standard Error 0.4 |
| Gefapixant 20 mg | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score At Day 85/Early Termination | 3.2 score on a scale | Standard Error 0.4 |
| Gefapixant 50 mg | Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score At Day 85/Early Termination | 4.0 score on a scale | Standard Error 0.5 |
Comparison: Day 85/Early Termination LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.062695% CI: [-0.1, 2.4]Mixed Effect Repeated Measures model
Comparison: Day 85/Early Termination LCQ Total Score: 20 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.096795% CI: [-0.2, 2.3]Mixed Effect Repeated Measures model
Comparison: Day 85/Early Termination LCQ Total Score: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.002895% CI: [0.7, 3.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Sleep Objective Cough Frequency After 12 Weeks of Treatment (Day 84)
Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency).
Time frame: Baseline (Study Day -1), Day 84
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Sleep Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.72 log coughs/hour | Standard Error 0.19 |
| Gefapixant 7.5 mg | Change From Baseline in Sleep Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.58 log coughs/hour | Standard Error 0.2 |
| Gefapixant 20 mg | Change From Baseline in Sleep Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.65 log coughs/hour | Standard Error 0.19 |
| Gefapixant 50 mg | Change From Baseline in Sleep Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | -0.44 log coughs/hour | Standard Error 0.2 |
Comparison: Day 84 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.610295% CI: [-0.4, 0.68]Mixed Effect Repeated Measures model
Comparison: Day 84 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.778295% CI: [-0.46, 0.61]Mixed Effect Repeated Measures model
Comparison: Day 84 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.316795% CI: [-0.27, 0.83]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Sleep Objective Cough Frequency After 4 Weeks of Treatment (Day 28)
Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency).
Time frame: Baseline (Study Day -1), Day 28
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Sleep Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.37 log coughs/hour | Standard Error 0.19 |
| Gefapixant 7.5 mg | Change From Baseline in Sleep Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.37 log coughs/hour | Standard Error 0.2 |
| Gefapixant 20 mg | Change From Baseline in Sleep Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.38 log coughs/hour | Standard Error 0.19 |
| Gefapixant 50 mg | Change From Baseline in Sleep Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | -0.49 log coughs/hour | Standard Error 0.2 |
Comparison: Day 28 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.985895% CI: [-0.53, 0.54]Mixed Effect Repeated Measures model
Comparison: Day 28 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.981395% CI: [-0.53, 0.52]Mixed Effect Repeated Measures model
Comparison: Day 28 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.674695% CI: [-0.65, 0.42]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Sleep Objective Cough Frequency After 8 Weeks of Treatment (Day 56)
Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency).
Time frame: Baseline (Study Day -1), Day 56
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Sleep Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.40 log coughs/hour | Standard Error 0.2 |
| Gefapixant 7.5 mg | Change From Baseline in Sleep Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.72 log coughs/hour | Standard Error 0.2 |
| Gefapixant 20 mg | Change From Baseline in Sleep Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.40 log coughs/hour | Standard Error 0.2 |
| Gefapixant 50 mg | Change From Baseline in Sleep Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | -0.80 log coughs/hour | Standard Error 0.21 |
Comparison: Day 56 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.982695% CI: [-0.55, 0.56]Mixed Effect Repeated Measures model
Comparison: Day 56 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.167295% CI: [-0.98, 0.17]Mixed Effect Repeated Measures model
Comparison: Day 56 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.p-value: 0.258395% CI: [-0.88, 0.24]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily Cough Score (DCS) at Week 1
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 1
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily Cough Score (DCS) at Week 1 | -1.1 score on a scale | Standard Error 0.18 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily Cough Score (DCS) at Week 1 | -0.7 score on a scale | Standard Error 0.18 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily Cough Score (DCS) at Week 1 | -0.8 score on a scale | Standard Error 0.19 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily Cough Score (DCS) at Week 1 | -1.1 score on a scale | Standard Error 0.19 |
Comparison: Week 1 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.192195% CI: [-0.2, 0.8]Mixed Effect Repeated Measures model
Comparison: Week 1 DCS Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.242895% CI: [-0.2, 0.8]Mixed Effect Repeated Measures model
Comparison: Week 1 DCS Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.738395% CI: [-0.6, 0.4]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily Cough Severity Diary (CSD) Total Score at Week 1
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 1
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily Cough Severity Diary (CSD) Total Score at Week 1 | -1.0 score on a scale | Standard Error 0.15 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily Cough Severity Diary (CSD) Total Score at Week 1 | -0.7 score on a scale | Standard Error 0.15 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily Cough Severity Diary (CSD) Total Score at Week 1 | -0.7 score on a scale | Standard Error 0.15 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily Cough Severity Diary (CSD) Total Score at Week 1 | -1.0 score on a scale | Standard Error 0.15 |
Comparison: Week 1 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.154595% CI: [-0.1, 0.7]Mixed Effect Repeated Measures model
Comparison: Week 1 CSD Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.201395% CI: [-0.1, 0.7]Mixed Effect Repeated Measures model
Comparison: Week 1 CSD Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.996295% CI: [-0.4, 0.4]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 10
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 10
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 10 | -1.2 score on a scale | Standard Error 0.22 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 10 | -1.4 score on a scale | Standard Error 0.22 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 10 | -1.6 score on a scale | Standard Error 0.22 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 10 | -1.9 score on a scale | Standard Error 0.22 |
Comparison: Week 10 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.626695% CI: [-0.8, 0.5]Mixed Effect Repeated Measures model
Comparison: Week 10 CSD Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.176995% CI: [-1, 0.2]Mixed Effect Repeated Measures model
Comparison: Week 10 CSD Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.031395% CI: [-1.3, -0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 11
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 11
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 11 | -1.1 score on a scale | Standard Error 0.22 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 11 | -1.5 score on a scale | Standard Error 0.22 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 11 | -1.7 score on a scale | Standard Error 0.22 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 11 | -1.9 score on a scale | Standard Error 0.23 |
Comparison: Week 11 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.205895% CI: [-1, 0.2]Mixed Effect Repeated Measures model
Comparison: Week 11 CSD Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.066595% CI: [-1.2, 0]Mixed Effect Repeated Measures model
Comparison: Week 11 CSD Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.015595% CI: [-1.4, -0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 12
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 12
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 12 | -1.2 score on a scale | Standard Error 0.22 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 12 | -1.5 score on a scale | Standard Error 0.22 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 12 | -1.7 score on a scale | Standard Error 0.22 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 12 | -1.9 score on a scale | Standard Error 0.23 |
Comparison: Week 12 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.245895% CI: [-1, 0.3]Mixed Effect Repeated Measures model
Comparison: Week 12 CSD Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.066295% CI: [-1.2, 0]Mixed Effect Repeated Measures model
Comparison: Week 12 CSD Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.019795% CI: [-1.4, -0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 2
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 2
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 2 | -1.0 score on a scale | Standard Error 0.18 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 2 | -0.9 score on a scale | Standard Error 0.19 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 2 | -1.0 score on a scale | Standard Error 0.19 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 2 | -1.5 score on a scale | Standard Error 0.19 |
Comparison: Week 2 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.732895% CI: [-0.4, 0.6]Mixed Effect Repeated Measures model
Comparison: Week 2 CSD Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.763595% CI: [-0.4, 0.6]Mixed Effect Repeated Measures model
Comparison: Week 2 CSD Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.095195% CI: [-0.9, 0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 3
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 3
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 3 | -1.0 score on a scale | Standard Error 0.2 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 3 | -1.2 score on a scale | Standard Error 0.2 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 3 | -1.3 score on a scale | Standard Error 0.2 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 3 | -1.5 score on a scale | Standard Error 0.2 |
Comparison: Week 3 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.579795% CI: [-0.7, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 3 CSD Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.249995% CI: [-0.9, 0.2]Mixed Effect Repeated Measures model
Comparison: Week 3 CSD Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.061295% CI: [-1.1, 0]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 4
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 4
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 4 | -1.2 score on a scale | Standard Error 0.2 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 4 | -1.4 score on a scale | Standard Error 0.2 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 4 | -1.5 score on a scale | Standard Error 0.2 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 4 | -1.7 score on a scale | Standard Error 0.2 |
Comparison: Week 4 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.535895% CI: [-0.7, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 4 CSD Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.312995% CI: [-0.8, 0.3]Mixed Effect Repeated Measures model
Comparison: Week 4 CSD Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.104695% CI: [-1, 0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 5
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 5
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 5 | -1.1 score on a scale | Standard Error 0.2 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 5 | -1.3 score on a scale | Standard Error 0.2 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 5 | -1.5 score on a scale | Standard Error 0.2 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 5 | -1.8 score on a scale | Standard Error 0.21 |
Comparison: Week 5 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.579695% CI: [-0.7, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 5 CSD Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.14395% CI: [-1, 0.1]Mixed Effect Repeated Measures model
Comparison: Week 5 CSD Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.022195% CI: [-1.2, -0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 6
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 6
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 6 | -1.0 score on a scale | Standard Error 0.21 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 6 | -1.4 score on a scale | Standard Error 0.21 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 6 | -1.5 score on a scale | Standard Error 0.21 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 6 | -1.7 score on a scale | Standard Error 0.21 |
Comparison: Week 6 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.156295% CI: [-1, 0.2]Mixed Effect Repeated Measures model
Comparison: Week 6 CSD Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.07195% CI: [-1.1, 0]Mixed Effect Repeated Measures model
Comparison: Week 6 CSD Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.027495% CI: [-1.2, -0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 7
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 7
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 7 | -1.2 score on a scale | Standard Error 0.21 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 7 | -1.4 score on a scale | Standard Error 0.22 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 7 | -1.5 score on a scale | Standard Error 0.22 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 7 | -1.7 score on a scale | Standard Error 0.22 |
Comparison: Week 7 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.446495% CI: [-0.8, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 7 CSD Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.33295% CI: [-0.9, 0.3]Mixed Effect Repeated Measures model
Comparison: Week 7 CSD Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.079295% CI: [-1.1, 0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 8
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 8
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 8 | -1.3 score on a scale | Standard Error 0.22 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 8 | -1.5 score on a scale | Standard Error 0.22 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 8 | -1.6 score on a scale | Standard Error 0.22 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 8 | -1.7 score on a scale | Standard Error 0.23 |
Comparison: Week 8 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.471695% CI: [-0.8, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 8 CSD Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.437195% CI: [-0.8, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 8 CSD Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.190795% CI: [-1, 0.2]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean Daily CSD Total Score at Week 9
The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).
Time frame: Baseline, Week 9
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 9 | -1.3 score on a scale | Standard Error 0.21 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 9 | -1.6 score on a scale | Standard Error 0.22 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 9 | -1.7 score on a scale | Standard Error 0.22 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean Daily CSD Total Score at Week 9 | -1.8 score on a scale | Standard Error 0.22 |
Comparison: Week 9 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.277295% CI: [-0.9, 0.3]Mixed Effect Repeated Measures model
Comparison: Week 9 CSD Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.113295% CI: [-1.1, 0.1]Mixed Effect Repeated Measures model
Comparison: Week 9 CSD Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.073795% CI: [-1.2, 0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 10
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 10
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 10 | -1.5 score on a scale | Standard Error 0.25 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 10 | -1.6 score on a scale | Standard Error 0.25 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 10 | -2.1 score on a scale | Standard Error 0.25 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 10 | -2.1 score on a scale | Standard Error 0.26 |
Comparison: Week 10 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.725595% CI: [-0.8, 0.6]Mixed Effect Repeated Measures model
Comparison: Week 10 DCS Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.091895% CI: [-1.3, 0.1]Mixed Effect Repeated Measures model
Comparison: Week 10 DCS Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.126395% CI: [-1.2, 0.2]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 11
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 11
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 11 | -1.5 score on a scale | Standard Error 0.25 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 11 | -1.8 score on a scale | Standard Error 0.25 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 11 | -2.1 score on a scale | Standard Error 0.25 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 11 | -2.2 score on a scale | Standard Error 0.26 |
Comparison: Week 11 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.405895% CI: [-1, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 11 DCS Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.082895% CI: [-1.3, 0.1]Mixed Effect Repeated Measures model
Comparison: Week 11 DCS Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.057595% CI: [-1.4, 0]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 12
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 12
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 12 | -1.5 score on a scale | Standard Error 0.26 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 12 | -1.8 score on a scale | Standard Error 0.26 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 12 | -2.2 score on a scale | Standard Error 0.26 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 12 | -2.2 score on a scale | Standard Error 0.27 |
Comparison: Week 12 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.416395% CI: [-1, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 12 DCS Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.088295% CI: [-1.3, 0.1]Mixed Effect Repeated Measures model
Comparison: Week 12 DCS Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.096195% CI: [-1.4, 0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 2
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 2
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 2 | -1.4 score on a scale | Standard Error 0.22 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 2 | -1.1 score on a scale | Standard Error 0.23 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 2 | -1.1 score on a scale | Standard Error 0.23 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 2 | -1.7 score on a scale | Standard Error 0.23 |
Comparison: Week 2 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.403395% CI: [-0.4, 0.9]Mixed Effect Repeated Measures model
Comparison: Week 2 DCS Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.459995% CI: [-0.4, 0.9]Mixed Effect Repeated Measures model
Comparison: Week 2 DCS Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.283795% CI: [-1, 0.3]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 3
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 3
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 3 | -1.4 score on a scale | Standard Error 0.24 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 3 | -1.3 score on a scale | Standard Error 0.24 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 3 | -1.6 score on a scale | Standard Error 0.25 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 3 | -1.7 score on a scale | Standard Error 0.25 |
Comparison: Week 3 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.808495% CI: [-0.6, 0.8]Mixed Effect Repeated Measures model
Comparison: Week 3 DCS Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.610895% CI: [-0.8, 0.5]Mixed Effect Repeated Measures model
Comparison: Week 3 DCS Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.42295% CI: [-0.9, 0.4]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 4
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 4
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 4 | -1.5 score on a scale | Standard Error 0.24 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 4 | -1.6 score on a scale | Standard Error 0.24 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 4 | -1.8 score on a scale | Standard Error 0.24 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 4 | -1.9 score on a scale | Standard Error 0.24 |
Comparison: Week 4 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.845795% CI: [-0.7, 0.6]Mixed Effect Repeated Measures model
Comparison: Week 4 DCS Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.404495% CI: [-0.9, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 4 DCS Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.303195% CI: [-1, 0.3]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 5
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 5
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 5 | -1.4 score on a scale | Standard Error 0.23 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 5 | -1.4 score on a scale | Standard Error 0.24 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 5 | -1.9 score on a scale | Standard Error 0.24 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 5 | -2.1 score on a scale | Standard Error 0.24 |
Comparison: Week 5 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.912695% CI: [-0.7, 0.6]Mixed Effect Repeated Measures model
Comparison: Week 5 DCS Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.113695% CI: [-1.2, 0.1]Mixed Effect Repeated Measures model
Comparison: Week 5 DCS Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.035295% CI: [-1.4, 0]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 6
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 6
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 6 | -1.2 score on a scale | Standard Error 0.24 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 6 | -1.7 score on a scale | Standard Error 0.24 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 6 | -1.9 score on a scale | Standard Error 0.24 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 6 | -1.8 score on a scale | Standard Error 0.24 |
Comparison: Week 6 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.171895% CI: [-1.1, 0.2]Mixed Effect Repeated Measures model
Comparison: Week 6 DCS Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.065195% CI: [-1.3, 0]Mixed Effect Repeated Measures model
Comparison: Week 6 DCS Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.084895% CI: [-1.2, 0.1]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 7
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 7
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 7 | -1.5 score on a scale | Standard Error 0.25 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 7 | -1.7 score on a scale | Standard Error 0.25 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 7 | -1.9 score on a scale | Standard Error 0.25 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 7 | -1.9 score on a scale | Standard Error 0.25 |
Comparison: Week 7 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.671595% CI: [-0.8, 0.5]Mixed Effect Repeated Measures model
Comparison: Week 7 DCS Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.351495% CI: [-1, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 7 DCS Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.280995% CI: [-1.1, 0.3]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 8
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 8
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 8 | -1.7 score on a scale | Standard Error 0.25 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 8 | -1.8 score on a scale | Standard Error 0.25 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 8 | -1.9 score on a scale | Standard Error 0.25 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 8 | -1.9 score on a scale | Standard Error 0.26 |
Comparison: Week 8 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.602295% CI: [-0.9, 0.5]Mixed Effect Repeated Measures model
Comparison: Week 8 DCS Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.445695% CI: [-1, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 8 DCS Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.462995% CI: [-1, 0.4]Mixed Effect Repeated Measures model
Secondary
Change From Baseline in Weekly Mean DCS at Week 9
The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.
Time frame: Baseline, Week 9
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean DCS at Week 9 | -1.6 score on a scale | Standard Error 0.25 |
| Gefapixant 7.5 mg | Change From Baseline in Weekly Mean DCS at Week 9 | -1.9 score on a scale | Standard Error 0.25 |
| Gefapixant 20 mg | Change From Baseline in Weekly Mean DCS at Week 9 | -2.2 score on a scale | Standard Error 0.25 |
| Gefapixant 50 mg | Change From Baseline in Weekly Mean DCS at Week 9 | -2.0 score on a scale | Standard Error 0.26 |
Comparison: Week 9 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.374995% CI: [-1, 0.4]Mixed Effect Repeated Measures model
Comparison: Week 9 DCS Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.085495% CI: [-1.3, 0.1]Mixed Effect Repeated Measures model
Comparison: Week 9 DCS Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate.p-value: 0.267295% CI: [-1.1, 0.3]Mixed Effect Repeated Measures model
Secondary
Percentage of Participants Rated as Very Much Improved or Much Improved by Clinicians According to the Clinician's Global Impression of Change (CGIC) at Day 85/Early Termination
The Clinician's Global Impression of Change (CGIC) reflects a clinician's belief about the efficacy of treatment. CGIC is a 7-point scale depicting a clinician's rating of a participant's overall improvement. Clinicians rated the participant's change at Week 12 (Day 85) as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the clinician's global perception of change were computed for each treatment group, and the percentage of participants rated by clinicians as having improvement (either very much improved or much improved on the CGIC scale) was reported for each treatment group.
Time frame: Day 85/Early Termination
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 85 CGIC observation during the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Rated as Very Much Improved or Much Improved by Clinicians According to the Clinician's Global Impression of Change (CGIC) at Day 85/Early Termination | 35.0 percentage of participants |
| Gefapixant 7.5 mg | Percentage of Participants Rated as Very Much Improved or Much Improved by Clinicians According to the Clinician's Global Impression of Change (CGIC) at Day 85/Early Termination | 53.4 percentage of participants |
| Gefapixant 20 mg | Percentage of Participants Rated as Very Much Improved or Much Improved by Clinicians According to the Clinician's Global Impression of Change (CGIC) at Day 85/Early Termination | 50.8 percentage of participants |
| Gefapixant 50 mg | Percentage of Participants Rated as Very Much Improved or Much Improved by Clinicians According to the Clinician's Global Impression of Change (CGIC) at Day 85/Early Termination | 64.9 percentage of participants |
Comparison: Day 85/Early Termination CGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.0396Cochran-Mantel-Haenszel
Comparison: Day 85/Early Termination CGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.0751Cochran-Mantel-Haenszel
Comparison: Day 85/Early Termination CGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Reporting Very Much Improved or Much Improved According to the Patient's Global Impression of Change (PGIC) After 4 Weeks of Treatment (Day 28)
The self-reported measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the participant's global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group.
Time frame: Day 28
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 28 PGIC observation during the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting Very Much Improved or Much Improved According to the Patient's Global Impression of Change (PGIC) After 4 Weeks of Treatment (Day 28) | 30.0 percentage of participants |
| Gefapixant 7.5 mg | Percentage of Participants Reporting Very Much Improved or Much Improved According to the Patient's Global Impression of Change (PGIC) After 4 Weeks of Treatment (Day 28) | 37.9 percentage of participants |
| Gefapixant 20 mg | Percentage of Participants Reporting Very Much Improved or Much Improved According to the Patient's Global Impression of Change (PGIC) After 4 Weeks of Treatment (Day 28) | 35.6 percentage of participants |
| Gefapixant 50 mg | Percentage of Participants Reporting Very Much Improved or Much Improved According to the Patient's Global Impression of Change (PGIC) After 4 Weeks of Treatment (Day 28) | 46.4 percentage of participants |
Comparison: Day 28 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.3182Cochran-Mantel-Haenszel
Comparison: Day 28 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.5021Cochran-Mantel-Haenszel
Comparison: Day 28 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.0665Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC After 8 Weeks of Treatment (Day 56)
The self-reported measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the participant's global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group.
Time frame: Day 56
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 56 PGIC observation during the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC After 8 Weeks of Treatment (Day 56) | 29.3 percentage of participants |
| Gefapixant 7.5 mg | Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC After 8 Weeks of Treatment (Day 56) | 44.8 percentage of participants |
| Gefapixant 20 mg | Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC After 8 Weeks of Treatment (Day 56) | 44.1 percentage of participants |
| Gefapixant 50 mg | Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC After 8 Weeks of Treatment (Day 56) | 60.8 percentage of participants |
Comparison: Day 56 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.0009Cochran-Mantel-Haenszel
Comparison: Day 56 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.0872Cochran-Mantel-Haenszel
Comparison: Day 56 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.0994Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC at Day 85/Early Termination
The self-reported measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the participant's global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group.
Time frame: Day 85/Early Termination
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 85 PGIC observation during the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC at Day 85/Early Termination | 28.3 percentage of participants |
| Gefapixant 7.5 mg | Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC at Day 85/Early Termination | 53.4 percentage of participants |
| Gefapixant 20 mg | Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC at Day 85/Early Termination | 49.2 percentage of participants |
| Gefapixant 50 mg | Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC at Day 85/Early Termination | 64.9 percentage of participants |
Comparison: Day 85/Early Termination PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.0037Cochran-Mantel-Haenszel
Comparison: Day 85/Early Termination PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: 0.0166Cochran-Mantel-Haenszel
Comparison: Day 85/Early Termination: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test.p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84)
24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 84.
Time frame: Baseline (Study Day -1), Day 84
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 84 endpoint observation during the treatment period.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥70% Change | 14.0 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥30% Change | 42.1 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥50% Change | 24.6 percentage of participants | 0.11 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥70% Change | 19.6 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥30% Change | 62.5 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥50% Change | 44.6 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥50% Change | 32.1 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥70% Change | 25.0 percentage of participants | 0.1 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥30% Change | 50.0 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥70% Change | 31.4 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥30% Change | 78.4 percentage of participants | 0.11 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥50% Change | 54.9 percentage of participants | 0.11 |
Comparison: Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.3845Cochran-Mantel-Haenszel
Comparison: Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.1177Cochran-Mantel-Haenszel
Comparison: Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0236Cochran-Mantel-Haenszel
Comparison: Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0192Cochran-Mantel-Haenszel
Comparison: Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.3301Cochran-Mantel-Haenszel
Comparison: Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0008Cochran-Mantel-Haenszel
Comparison: Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0285Cochran-Mantel-Haenszel
Comparison: Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.3856Cochran-Mantel-Haenszel
Comparison: Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28)
24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 28.
Time frame: Baseline (Study Day -1), Day 28
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 28 endpoint observation during the treatment period.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥70% Change | 13.3 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥30% Change | 51.7 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥50% Change | 21.7 percentage of participants | 0.11 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥70% Change | 25.5 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥30% Change | 58.2 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥50% Change | 34.5 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥50% Change | 30.5 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥70% Change | 15.3 percentage of participants | 0.1 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥30% Change | 45.8 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥70% Change | 34.5 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥30% Change | 67.3 percentage of participants | 0.11 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥50% Change | 50.9 percentage of participants | 0.11 |
Comparison: Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0781Cochran-Mantel-Haenszel
Comparison: Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.7098Cochran-Mantel-Haenszel
Comparison: Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0068Cochran-Mantel-Haenszel
Comparison: Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.1284Cochran-Mantel-Haenszel
Comparison: Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.267Cochran-Mantel-Haenszel
Comparison: Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0013Cochran-Mantel-Haenszel
Comparison: Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.4343Cochran-Mantel-Haenszel
Comparison: Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.5384Cochran-Mantel-Haenszel
Comparison: Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0822Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56)
24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 56.
Time frame: Baseline (Study Day -1), Day 56
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 56 endpoint observation during the treatment period.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥70% Change | 7.0 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥30% Change | 45.6 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥50% Change | 28.1 percentage of participants | 0.11 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥70% Change | 32.1 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥30% Change | 62.5 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥50% Change | 50.0 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥50% Change | 32.2 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥70% Change | 22.0 percentage of participants | 0.1 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥30% Change | 54.2 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥70% Change | 37.3 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥30% Change | 78.4 percentage of participants | 0.11 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥50% Change | 52.9 percentage of participants | 0.11 |
Comparison: Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0006Cochran-Mantel-Haenszel
Comparison: Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0223Cochran-Mantel-Haenszel
Comparison: Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0001Cochran-Mantel-Haenszel
Comparison: Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0165Cochran-Mantel-Haenszel
Comparison: Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.6255Cochran-Mantel-Haenszel
Comparison: Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0085Cochran-Mantel-Haenszel
Comparison: Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0722Cochran-Mantel-Haenszel
Comparison: Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.3577Cochran-Mantel-Haenszel
Comparison: Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0006Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98)
24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 14 (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 98.
Time frame: Baseline (Study Day -1), Day 98
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 98 endpoint observation during the treatment period.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥70% Change | 12.1 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥30% Change | 46.6 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥50% Change | 25.9 percentage of participants | 0.11 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥70% Change | 20.0 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥30% Change | 52.7 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥50% Change | 34.5 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥50% Change | 25.0 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥70% Change | 16.1 percentage of participants | 0.1 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥30% Change | 46.4 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥70% Change | 21.6 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥30% Change | 54.9 percentage of participants | 0.11 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥50% Change | 39.2 percentage of participants | 0.11 |
Comparison: Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.2441Cochran-Mantel-Haenszel
Comparison: Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.5055Cochran-Mantel-Haenszel
Comparison: Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.1602Cochran-Mantel-Haenszel
Comparison: Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.2721Cochran-Mantel-Haenszel
Comparison: Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.9763Cochran-Mantel-Haenszel
Comparison: Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0993Cochran-Mantel-Haenszel
Comparison: Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.4575Cochran-Mantel-Haenszel
Comparison: Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.9706Cochran-Mantel-Haenszel
Comparison: Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.3258Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84)
Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 84.
Time frame: Baseline (Study Day -1), Day 84
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 84 endpoint observation during the treatment period.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥70% Change | 15.8 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥30% Change | 43.9 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥50% Change | 24.6 percentage of participants | 0.11 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥70% Change | 21.4 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥30% Change | 64.3 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥50% Change | 44.6 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥50% Change | 32.1 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥70% Change | 23.2 percentage of participants | 0.1 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥30% Change | 48.2 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥70% Change | 31.4 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥30% Change | 80.4 percentage of participants | 0.11 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84) | ≥50% Change | 51.0 percentage of participants | 0.11 |
Comparison: Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.3893Cochran-Mantel-Haenszel
Comparison: Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.2803Cochran-Mantel-Haenszel
Comparison: Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0427Cochran-Mantel-Haenszel
Comparison: Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0209Cochran-Mantel-Haenszel
Comparison: Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.3401Cochran-Mantel-Haenszel
Comparison: Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0031Cochran-Mantel-Haenszel
Comparison: Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0283Cochran-Mantel-Haenszel
Comparison: Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.6233Cochran-Mantel-Haenszel
Comparison: Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28)
Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 28.
Time frame: Baseline (Study Day -1), Day 28
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 28 endpoint observation during the treatment period.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥70% Change | 15.0 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥30% Change | 46.7 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥50% Change | 23.3 percentage of participants | 0.11 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥70% Change | 25.5 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥30% Change | 63.6 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥50% Change | 38.2 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥50% Change | 30.5 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥70% Change | 16.9 percentage of participants | 0.1 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥30% Change | 50.8 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥70% Change | 34.5 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥30% Change | 60.0 percentage of participants | 0.11 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28) | ≥50% Change | 47.3 percentage of participants | 0.11 |
Comparison: Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.1387Cochran-Mantel-Haenszel
Comparison: Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.7238Cochran-Mantel-Haenszel
Comparison: Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0144Cochran-Mantel-Haenszel
Comparison: Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0922Cochran-Mantel-Haenszel
Comparison: Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.3812Cochran-Mantel-Haenszel
Comparison: Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0088Cochran-Mantel-Haenszel
Comparison: Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0653Cochran-Mantel-Haenszel
Comparison: Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.6443Cochran-Mantel-Haenszel
Comparison: Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.1511Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56)
Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 56.
Time frame: Baseline (Study Day -1), Day 56
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 56 endpoint observation during the treatment period.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥70% Change | 10.5 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥30% Change | 47.4 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥50% Change | 26.3 percentage of participants | 0.11 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥70% Change | 32.1 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥30% Change | 64.3 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥50% Change | 46.4 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥50% Change | 39.0 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥70% Change | 22.0 percentage of participants | 0.1 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥30% Change | 55.9 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥70% Change | 31.4 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥30% Change | 72.5 percentage of participants | 0.11 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56) | ≥50% Change | 54.9 percentage of participants | 0.11 |
Comparison: Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0045Cochran-Mantel-Haenszel
Comparison: Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0947Cochran-Mantel-Haenszel
Comparison: Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.008Cochran-Mantel-Haenszel
Comparison: Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0283Cochran-Mantel-Haenszel
Comparison: Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.1493Cochran-Mantel-Haenszel
Comparison: Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0026Cochran-Mantel-Haenszel
Comparison: Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0652Cochran-Mantel-Haenszel
Comparison: Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.3601Cochran-Mantel-Haenszel
Comparison: Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0086Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98)
Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at the Follow-up visit (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 98.
Time frame: Baseline (Study Day -1), Day 98
Population: All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 98 endpoint observation during the treatment period.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥70% Change | 13.8 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥30% Change | 51.7 percentage of participants | 0.1 |
| Placebo | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥50% Change | 25.9 percentage of participants | 0.11 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥70% Change | 18.2 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥30% Change | 56.4 percentage of participants | 0.1 |
| Gefapixant 7.5 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥50% Change | 32.7 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥50% Change | 25.0 percentage of participants | 0.11 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥70% Change | 14.3 percentage of participants | 0.1 |
| Gefapixant 20 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥30% Change | 50.0 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥70% Change | 23.5 percentage of participants | 0.1 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥30% Change | 58.8 percentage of participants | 0.11 |
| Gefapixant 50 mg | Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98) | ≥50% Change | 39.2 percentage of participants | 0.11 |
Comparison: Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.4925Cochran-Mantel-Haenszel
Comparison: Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.9007Cochran-Mantel-Haenszel
Comparison: Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.1602Cochran-Mantel-Haenszel
Comparison: Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.344Cochran-Mantel-Haenszel
Comparison: Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.9876Cochran-Mantel-Haenszel
Comparison: Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.0993Cochran-Mantel-Haenszel
Comparison: Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.5968Cochran-Mantel-Haenszel
Comparison: Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.8726Cochran-Mantel-Haenszel
Comparison: Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing.p-value: 0.4092Cochran-Mantel-Haenszel
Secondary
Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84)
The tolerance to taste-related adverse events (AEs) was evaluated at the end of the study (Day 84) and a structured taste questionnaire was administered to participants experiencing a taste-related AE. Participants were asked to indicate the frequency that they experienced the taste effect by answering the question How frequently do you experience the taste effect after taking each dose of medication? The counts and percentages of categorical frequency responses to the individual items were computed for each treatment group.
Time frame: Day 84
Population: All randomized participants who had taken at least 1 dose of study medication, who had experienced a taste-related AE, and who had Day 84 taste questionnaire data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted | 96.5 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Always | 0.0 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Almost Always | 0.0 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Never | 1.8 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted + Never | 98.2 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Occasionally | 1.8 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Often | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Always | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Often | 1.8 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Occasionally | 1.8 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Almost Always | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted + Never | 96.4 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Never | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted | 96.4 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Often | 7.0 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted | 61.4 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Never | 0.0 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Occasionally | 8.8 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Almost Always | 7.0 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Always | 15.8 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted + Never | 61.4 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Occasionally | 0.0 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted + Never | 35.3 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Always | 51.0 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Never | 0.0 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted | 35.3 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Almost Always | 9.8 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84) | Often | 3.9 percentage of participants |
Comparison: Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0.6115Cochran-Mantel-Haenszel
Comparison: Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84)
The tolerance to taste-related adverse events (AEs) was evaluated at the end of the study (Day 84) and a structured taste questionnaire was administered to participants experiencing a taste-related AE to determine what degree the participant found the taste effect bothersome by answering the question How bothersome is the taste effect of the medication? The counts and percentages of categorical responses to the individual items were computed for each treatment group.
Time frame: Day 84
Population: All randomized participants who had taken at least 1 dose of study medication, who had experienced a taste-related AE, and who had Day 84 taste questionnaire data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted | 96.5 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Extremely | 0.0 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Very | 0.0 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Not At All | 3.5 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted + Not At All | 100.0 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | A Little | 0.0 percentage of participants |
| Placebo | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Somewhat | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Extremely | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Somewhat | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | A Little | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Very | 0.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted + Not At All | 100.0 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Not At All | 3.6 percentage of participants |
| Gefapixant 7.5 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted | 96.4 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Somewhat | 17.5 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted | 61.4 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Not At All | 7.0 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | A Little | 8.8 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Very | 5.3 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Extremely | 0.0 percentage of participants |
| Gefapixant 20 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted + Not At All | 68.4 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | A Little | 3.9 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted + Not At All | 41.2 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Extremely | 11.8 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Not At All | 5.9 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | No Taste Effect Noted | 35.3 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Very | 29.4 percentage of participants |
| Gefapixant 50 mg | Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84) | Somewhat | 13.7 percentage of participants |
Comparison: Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: 0Cochran-Mantel-Haenszel
Comparison: Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test.p-value: <0.0001Cochran-Mantel-Haenszel