Cough, Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
ORV-PF-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with IPF.
Detailed description
The study will be a multi-center, double-blind, randomised, placebo-controlled 2-period cross-over study in subjects with chronic cough due to idiopathic pulmonary fibrosis (IPF). Subjects will participate in one of two cohorts (Cohort 1 and Cohort 2). Cohort 1 will evaluate a 30 mg orvepitant dose and Cohort 2 the 10 mg dose. Within each cohort, subjects will be randomised to receive either orvepitant or placebo in the first treatment period (Treatment Period A) followed by the alternate treatment in Treatment Period B. There will be a wash-out period of 3 weeks between the two treatment periods. Subjects will be randomised 1:1 to each of the two treatment orders and 1:1 to each cohort. Subjects will enter a screening period of between 14 and 28 days to determine eligibility. Eligible subjects will be randomised at the Baseline visit and will participate in two identical 28 day treatment periods with the wash-out period between them. There will be a total of 8 visits including the Screening, Baseline and final Follow-up visits.
Interventions
Orvepitant tablets 30mg or 10mg
DRUGPlacebo
Placebo tablets to match orvepitant 30mg and 10mg tablets
Sponsors
Pharm-Olam International
Nerre Therapeutics Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of IPF established according to the 2018 or 2022 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline * FEV1/FVC ratio ≥0.65 at the screening visit * Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25% within 12 months of the screening visit * Arterial oxygen saturation on room air or oxygen ≥90% at Screening * Life expectancy of at least 12 months * Cough that is attributed to IPF, which has not responded to anti-tussive treatment, and which has been present for at least 8 weeks prior to Screening * Mean daily IPF Coughing Severity Scale score ≥5 (after rounding) during the second week of the baseline assessment period Key
Exclusion criteria
* Recent respiratory tract infection (\<8 weeks prior to Screening) * Recent acute exacerbation of IPF (\<8 weeks prior to Screening) * Current smokers or ex-smokers with \<6 months' abstinence prior to Screening * Emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is greater than the extent of fibrosis according to the reported results of the most recent scan * Mean early morning cough scale score ≥5 and rest of the day cough scale score \<5 (after rounding) during the second week of the baseline assessment period (assessed at Visit 2) * Cough that is predominantly productive in nature and attributable to lung pathology such as chronic bronchitis or bronchiectasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS) | Week 4 | A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity in the last 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale | Week 4 | A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for severity of any other coughing during the last 24 hours, excluding coughing first thing in the morning |
| Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale | Week 4 | A numerical rating scale from 0 (no urge to cough) to 10 (urge to cough as bad as you can imagine) for severity of urge to cough in the last 24 hours |
| Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale | Week 4 | A 5-point verbal rating scale for cough frequency over the last 24 hours with response options from 'never' to 'all the time'. The verbal responses were converted to a number (0 = never, 4 = all the time). |
| Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale | Week 4 | A numerical rating scale from 0 (no shortness of breath) to 10 (shortness of breath as bad as you can imagine) for severity of shortness of breath in the last 24 hours |
| Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score | Week 4 | The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the total score. |
| Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score | Week 4 | The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the physical domain score. |
| Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale | Week 4 | A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity first thing in the morning |
| Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score | Week 4 | The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the social domain score. |
| Mean Change From Baseline in 24-hour Cough Frequency | Week 4 | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) |
| Mean Change From Baseline in Awake Cough Frequency | Week 4 | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) |
| Mean Change From Baseline in Night-time Cough Frequency | Week 4 | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) |
| Mean Change From Baseline in the Number of Coughing Bouts | Week 4 | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) |
| Mean Change From Baseline in the Number of Coughs Per Bout | Week 4 | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) |
| Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score | Week 4 | The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the psychological domain score. |
Countries
Netherlands, United Kingdom, United States
Participant flow
Recruitment details
80 participants were enrolled into the study. 40 were randomised to the orvepitant 10 mg cohort and 40 to the orvepitant 30 mg cohort.
Pre-assignment details
This was a crossover study so each participant was to receive both orvepitant and placebo.
Participants by arm
| Arm | Count |
|---|---|
| Orvepitant 10 mg Cohort Participants randomised to the orvepitant 10 mg cohort. They were randomised to receive either orvepitant 10 mg or placebo in the first treatment period (Treatment Period A), followed by the alternate treatment in Treatment Period B. | 40 |
| Orvepitant 30 mg Cohort Participants randomised to the orvepitant 30 mg cohort. They were randomised to receive either orvepitant 30 mg or placebo in the first treatment period (Treatment Period A), followed by the alternate treatment in Treatment Period B. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| First Intervention (4 weeks) | Adverse Event | 0 | 0 | 0 | 1 |
| Second Intervention (4 weeks) | Adverse Event | 1 | 0 | 0 | 0 |
| Second Intervention (4 weeks) | Death | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Orvepitant 10 mg Cohort | Orvepitant 30 mg Cohort | Total |
|---|---|---|---|
| Age, Continuous | 71.4 Years STANDARD_DEVIATION 6.55 | 72.4 Years STANDARD_DEVIATION 7.79 | 71.9 Years STANDARD_DEVIATION 7.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 37 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 40 Participants | 37 Participants | 77 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 30 Participants | 29 Participants | 59 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 | 1 / 40 | 0 / 40 | 0 / 38 | 0 / 39 |
| other Total, other adverse events | 18 / 40 | 30 / 40 | 17 / 38 | 20 / 39 |
| serious Total, serious adverse events | 2 / 40 | 1 / 40 | 3 / 38 | 1 / 39 |
Outcome results
Primary
Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS)
A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity in the last 24 hours
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS) | -0.69 Points | Standard Deviation 1.583 |
| Orvepitant 10 mg | Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS) | -0.66 Points | Standard Deviation 1.276 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS) | -0.26 Points | Standard Deviation 1.155 |
| Orvepitant 30 mg | Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS) | -0.85 Points | Standard Deviation 1.465 |
p-value: 0.98995% CI: [-0.62, 0.63]ANCOVA
p-value: 0.05495% CI: [-1.16, 0.01]ANCOVA
Secondary
Mean Change From Baseline in 24-hour Cough Frequency
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Time frame: Week 4
Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in 24-hour Cough Frequency | 0.93 Coughs/hour ratio vs baseline | Standard Error 1.114 |
| Orvepitant 10 mg | Mean Change From Baseline in 24-hour Cough Frequency | 1.00 Coughs/hour ratio vs baseline | Standard Error 1.115 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in 24-hour Cough Frequency | 0.84 Coughs/hour ratio vs baseline | Standard Error 1.113 |
| Orvepitant 30 mg | Mean Change From Baseline in 24-hour Cough Frequency | 0.87 Coughs/hour ratio vs baseline | Standard Error 1.112 |
p-value: 0.43895% CI: [0.88, 1.33]ANCOVA
p-value: 0.76195% CI: [0.82, 1.31]ANCOVA
Secondary
Mean Change From Baseline in Awake Cough Frequency
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Time frame: Week 4
Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Awake Cough Frequency | 0.95 Awake coughs/hour ratio vs baseline | Standard Error 1.119 |
| Orvepitant 10 mg | Mean Change From Baseline in Awake Cough Frequency | 1.03 Awake coughs/hour ratio vs baseline | Standard Error 1.121 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Awake Cough Frequency | 0.84 Awake coughs/hour ratio vs baseline | Standard Error 1.122 |
| Orvepitant 30 mg | Mean Change From Baseline in Awake Cough Frequency | 0.87 Awake coughs/hour ratio vs baseline | Standard Error 1.121 |
p-value: 0.44995% CI: [0.88, 1.34]ANCOVA
p-value: 0.73295% CI: [0.82, 1.32]ANCOVA
Secondary
Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score
The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the physical domain score.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score | 0.18 Points | Standard Deviation 0.656 |
| Orvepitant 10 mg | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score | 0.26 Points | Standard Deviation 0.717 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score | 0.06 Points | Standard Deviation 0.75 |
| Orvepitant 30 mg | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score | 0.36 Points | Standard Deviation 0.638 |
p-value: 0.63395% CI: [-0.22, 0.35]ANCOVA
p-value: 0.06395% CI: [-0.02, 0.56]ANCOVA
Secondary
Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score
The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the psychological domain score.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score | 0.57 Points | Standard Deviation 0.935 |
| Orvepitant 10 mg | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score | 0.47 Points | Standard Deviation 0.906 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score | 0.12 Points | Standard Deviation 1.004 |
| Orvepitant 30 mg | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score | 0.63 Points | Standard Deviation 0.984 |
p-value: 0.73295% CI: [-0.44, 0.31]ANCOVA
p-value: 0.04495% CI: [0.01, 0.89]ANCOVA
Secondary
Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score
The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the social domain score.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score | 0.32 Points | Standard Deviation 0.885 |
| Orvepitant 10 mg | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score | 0.54 Points | Standard Deviation 0.95 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score | -0.03 Points | Standard Deviation 1.202 |
| Orvepitant 30 mg | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score | 0.60 Points | Standard Deviation 1.068 |
p-value: 0.31895% CI: [-0.19, 0.58]ANCOVA
p-value: 0.0395% CI: [0.05, 0.98]ANCOVA
Secondary
Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score
The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the total score.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score | 1.07 Points | Standard Deviation 2.218 |
| Orvepitant 10 mg | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score | 1.27 Points | Standard Deviation 2.187 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score | 0.14 Points | Standard Deviation 2.724 |
| Orvepitant 30 mg | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score | 1.60 Points | Standard Deviation 2.353 |
p-value: 0.67895% CI: [-0.73, 1.11]ANCOVA
p-value: 0.02595% CI: [0.16, 2.31]ANCOVA
Secondary
Mean Change From Baseline in Night-time Cough Frequency
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Time frame: Week 4
Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Night-time Cough Frequency | 0.79 Asleep coughs/hour ratio vs baseline | Standard Error 1.18 |
| Orvepitant 10 mg | Mean Change From Baseline in Night-time Cough Frequency | 0.90 Asleep coughs/hour ratio vs baseline | Standard Error 1.184 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Night-time Cough Frequency | 0.87 Asleep coughs/hour ratio vs baseline | Standard Error 1.149 |
| Orvepitant 30 mg | Mean Change From Baseline in Night-time Cough Frequency | 0.85 Asleep coughs/hour ratio vs baseline | Standard Error 1.145 |
p-value: 0.495% CI: [0.84, 1.54]ANCOVA
p-value: 0.91295% CI: [0.69, 1.4]ANCOVA
Secondary
Mean Change From Baseline in the Number of Coughing Bouts
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Time frame: Week 4
Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in the Number of Coughing Bouts | 0.91 Bouts/hour ratio vs baseline | Standard Error 1.089 |
| Orvepitant 10 mg | Mean Change From Baseline in the Number of Coughing Bouts | 1.00 Bouts/hour ratio vs baseline | Standard Error 1.09 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in the Number of Coughing Bouts | 0.82 Bouts/hour ratio vs baseline | Standard Error 1.087 |
| Orvepitant 30 mg | Mean Change From Baseline in the Number of Coughing Bouts | 0.88 Bouts/hour ratio vs baseline | Standard Error 1.087 |
p-value: 0.28795% CI: [0.93, 1.29]ANCOVA
p-value: 0.4295% CI: [0.9, 1.29]ANCOVA
Secondary
Mean Change From Baseline in the Number of Coughs Per Bout
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Time frame: Week 4
Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in the Number of Coughs Per Bout | 0.91 Coughs per bout ratio vs baseline | Standard Error 1.027 |
| Orvepitant 10 mg | Mean Change From Baseline in the Number of Coughs Per Bout | 0.92 Coughs per bout ratio vs baseline | Standard Error 1.027 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in the Number of Coughs Per Bout | 0.98 Coughs per bout ratio vs baseline | Standard Error 1.028 |
| Orvepitant 30 mg | Mean Change From Baseline in the Number of Coughs Per Bout | 0.89 Coughs per bout ratio vs baseline | Standard Error 1.028 |
p-value: 0.76595% CI: [0.96, 1.05]ANCOVA
p-value: 0.00495% CI: [0.85, 0.97]ANCOVA
Secondary
Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale
A 5-point verbal rating scale for cough frequency over the last 24 hours with response options from 'never' to 'all the time'. The verbal responses were converted to a number (0 = never, 4 = all the time).
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale | -0.20 Points | Standard Deviation 0.574 |
| Orvepitant 10 mg | Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale | -0.15 Points | Standard Deviation 0.543 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale | -0.06 Points | Standard Deviation 0.369 |
| Orvepitant 30 mg | Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale | -0.29 Points | Standard Deviation 0.462 |
p-value: 0.6595% CI: [-0.17, 0.26]ANCOVA
p-value: 0.0195% CI: [-0.41, -0.06]ANCOVA
Secondary
Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale
A numerical rating scale from 0 (no shortness of breath) to 10 (shortness of breath as bad as you can imagine) for severity of shortness of breath in the last 24 hours
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale | -0.26 Points | Standard Deviation 1.192 |
| Orvepitant 10 mg | Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale | -0.22 Points | Standard Deviation 0.988 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale | 0.00 Points | Standard Deviation 0.764 |
| Orvepitant 30 mg | Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale | -0.44 Points | Standard Deviation 1.06 |
p-value: 0.85695% CI: [-0.44, 0.53]ANCOVA
p-value: 0.03695% CI: [-0.87, -0.03]ANCOVA
Secondary
Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale
A numerical rating scale from 0 (no urge to cough) to 10 (urge to cough as bad as you can imagine) for severity of urge to cough in the last 24 hours
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale | -0.46 Points | Standard Deviation 1.517 |
| Orvepitant 10 mg | Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale | -0.63 Points | Standard Deviation 1.209 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale | -0.30 Points | Standard Deviation 0.974 |
| Orvepitant 30 mg | Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale | -0.76 Points | Standard Deviation 1.4 |
p-value: 0.63995% CI: [-0.73, 0.45]ANCOVA
p-value: 0.09295% CI: [-1, 0.08]ANCOVA
Secondary
Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale
A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity first thing in the morning
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale | -0.57 Points | Standard Deviation 1.505 |
| Orvepitant 10 mg | Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale | -0.51 Points | Standard Deviation 1.199 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale | -0.49 Points | Standard Deviation 1.184 |
| Orvepitant 30 mg | Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale | -1.08 Points | Standard Deviation 1.627 |
p-value: 0.87295% CI: [-0.52, 0.62]ANCOVA
p-value: 0.04195% CI: [-1.14, -0.02]ANCOVA
Secondary
Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale
A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for severity of any other coughing during the last 24 hours, excluding coughing first thing in the morning
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (10 mg Cohort) | Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale | -0.62 Points | Standard Deviation 1.477 |
| Orvepitant 10 mg | Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale | -0.62 Points | Standard Deviation 1.306 |
| Placebo (30 mg Cohort) | Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale | -0.44 Points | Standard Deviation 1.117 |
| Orvepitant 30 mg | Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale | -0.80 Points | Standard Deviation 1.528 |
p-value: 0.99195% CI: [-0.61, 0.6]ANCOVA
p-value: 0.21595% CI: [-0.97, 0.22]ANCOVA