Asthma
Conditions
Keywords
Asthma, Staged withdrawal of background therapy
Brief summary
The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.
Detailed description
Study terminated on 7th April 2015. The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study
Interventions
DRUGPlacebo
680 micrograms BID, Orally inhaled placebo for 12 weeks
DRUGPF-03715455
680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks
Sponsors
Pfizer
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with a physician documented history or diagnosis of persistent asthma (according to GINA, 2014 definition of asthma), * Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted. * Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol combination therapy, or budesonide/formoterol combination therapy or mometasone/formoterol combination therapy. * Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than or equal to 3.0)
Exclusion criteria
* Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis, Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis, tuberculosis). * Subjects who are current smokers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Asthma Worsening Events | Baseline up to follow-up period (Week 16) | Asthma worsening was defined as one of the following events: greater than or equal to (\>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; \>=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids \>=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, Week 1, Week 2, Week 3, and Week 4 | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Baseline was defined as the latest measurement before first dosing. |
| Change From Baseline in Forced Vital Capacity (FVC) | Baseline, Week 1, Week 2, Week 3, and Week 4 | FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. |
| Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Baseline, Week 1, Week 2, Week 3, and Week 4 | FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. |
| Change From Baseline in Asthma Symptom Scores | Baseline, Week 1, Week 2, Week 3, and Week 4 | Participants used a daily diary assessment to record overall asthma symptom scores twice a day (morning and evening). Questions included extent of albuterol use, symptoms of wheezing, breathlessness, chest tightness, and cough. The visit dependent asthma symptom scores were calculated based on the item in the daily diary assessment. A participant summarized her/his daily frequency of asthma symptoms during the last 24 hours by the assignment of an integer score (0,1,2,3 or 4). The score=0 value denoted the day without symptoms and the score=4 value denoted the day where symptoms occurred all of the time. The asthma symptom scores were calculated by averaging the values of the daily scores within visit-dependent time window. Higher score indicates asthma worsening |
| Time to Asthma Worsening Event | Baseline up to follow-up period (Week 16) | The time post randomization that the first asthma worsening event occurred (defined above). |
| Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Baseline, Week 1, Week 2, Week 3, and Week 4 | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. The changes from baseline (CFB) at each week and over 4 weeks were analyzed. |
| Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Baseline, Week 1, Week 2, Week 3, and Week 4 | The 5-question version of the Juniper ACQ is a validated questionnaire to evaluate asthma control. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of \<= 0.75 indicate well-controlled asthma, scores between 0.76 and less than (\<) 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma. |
| Number of Daily Puffs of Rescue Medication | Baseline, Week 1, Week 2, Week 3, and Week 4 | The use of rescue bronchodilators (albuterol or levalbuterol) for symptomatic relief of asthma in a 24-hour period was recorded by the participant. |
| Number of Night Time Awakenings Per Week | Baseline, Week 1, Week 2, Week 3, and Week 4 | The number of nocturnal awakenings due to asthma symptoms was recorded by the participant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Twice Daily Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler. | 26 |
| PF-03715455 680 mcg Twice Daily Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 |
| Overall Study | No longer meets eligibility criteria | 1 | 0 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Study terminated by sponsor | 16 | 15 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo Twice Daily | PF-03715455 680 mcg Twice Daily | Total |
|---|---|---|---|
| Age, Continuous | 42.3 years STANDARD_DEVIATION 14.1 | 44.2 years STANDARD_DEVIATION 10 | 43.2 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 26 | 15 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 |
Outcome results
Primary
Percentage of Participants With Asthma Worsening Events
Asthma worsening was defined as one of the following events: greater than or equal to (\>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; \>=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids \>=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma.
Time frame: Baseline up to follow-up period (Week 16)
Population: The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Twice Daily | Percentage of Participants With Asthma Worsening Events | 11.5 percentage of participants |
| PF-03715455 680 mcg Twice Daily | Percentage of Participants With Asthma Worsening Events | 16.0 percentage of participants |
Secondary
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4
The 5-question version of the Juniper ACQ is a validated questionnaire to evaluate asthma control. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of \<= 0.75 indicate well-controlled asthma, scores between 0.76 and less than (\<) 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Change at Week 1 | -0.50 units on a scale | Standard Deviation 0.742 |
| Placebo Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Change at Week 3 | -0.62 units on a scale | Standard Deviation 0.959 |
| Placebo Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Change at Week 2 | -0.66 units on a scale | Standard Deviation 0.826 |
| Placebo Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Change at Week 4 | -0.71 units on a scale | Standard Deviation 0.838 |
| Placebo Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Baseline | 2.18 units on a scale | Standard Deviation 0.315 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Change at Week 4 | -0.41 units on a scale | Standard Deviation 0.806 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Baseline | 2.17 units on a scale | Standard Deviation 0.489 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Change at Week 1 | -0.27 units on a scale | Standard Deviation 0.658 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Change at Week 2 | -0.53 units on a scale | Standard Deviation 0.67 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 | Change at Week 3 | -0.34 units on a scale | Standard Deviation 0.751 |
Secondary
Change From Baseline in Asthma Symptom Scores
Participants used a daily diary assessment to record overall asthma symptom scores twice a day (morning and evening). Questions included extent of albuterol use, symptoms of wheezing, breathlessness, chest tightness, and cough. The visit dependent asthma symptom scores were calculated based on the item in the daily diary assessment. A participant summarized her/his daily frequency of asthma symptoms during the last 24 hours by the assignment of an integer score (0,1,2,3 or 4). The score=0 value denoted the day without symptoms and the score=4 value denoted the day where symptoms occurred all of the time. The asthma symptom scores were calculated by averaging the values of the daily scores within visit-dependent time window. Higher score indicates asthma worsening
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Asthma Symptom Scores | Change at Week 1 | -0.14 units on a scale | Standard Deviation 0.406 |
| Placebo Twice Daily | Change From Baseline in Asthma Symptom Scores | Change at Week 3 | -0.15 units on a scale | Standard Deviation 0.471 |
| Placebo Twice Daily | Change From Baseline in Asthma Symptom Scores | Change at Week 2 | -0.17 units on a scale | Standard Deviation 0.497 |
| Placebo Twice Daily | Change From Baseline in Asthma Symptom Scores | Change at Week 4 | -0.19 units on a scale | Standard Deviation 0.565 |
| Placebo Twice Daily | Change From Baseline in Asthma Symptom Scores | Baseline | 1.15 units on a scale | Standard Deviation 0.567 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Symptom Scores | Change at Week 4 | -0.38 units on a scale | Standard Deviation 0.513 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Symptom Scores | Baseline | 1.23 units on a scale | Standard Deviation 0.636 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Symptom Scores | Change at Week 1 | -0.12 units on a scale | Standard Deviation 0.453 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Symptom Scores | Change at Week 2 | -0.36 units on a scale | Standard Deviation 0.56 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Asthma Symptom Scores | Change at Week 3 | -0.44 units on a scale | Standard Deviation 0.458 |
Comparison: Change From Baseline Averaged Over Week 1 to 490% CI: [-0.285, 0.106]Longitudinal Analysis of Covariance
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Baseline was defined as the latest measurement before first dosing.
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline at Week 1 | 0.188 liters | Standard Deviation 0.3941 |
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline at Week 3 | 0.273 liters | Standard Deviation 0.3444 |
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline at Week 2 | 0.244 liters | Standard Deviation 0.3797 |
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline at Week 4 | 0.234 liters | Standard Deviation 0.3251 |
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline | 2.084 liters | Standard Deviation 0.4645 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline at Week 4 | 0.148 liters | Standard Deviation 0.2217 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline | 2.158 liters | Standard Deviation 0.4917 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline at Week 1 | 0.111 liters | Standard Deviation 0.2226 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline at Week 2 | 0.107 liters | Standard Deviation 0.1959 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline at Week 3 | 0.124 liters | Standard Deviation 0.214 |
Comparison: Change From Baseline at Week 190% CI: [-0.2243, 0.0805]Longitudinal Analysis of Covariance
Comparison: Change From Baseline at Week 290% CI: [-0.2362, 0.0523]Longitudinal Analysis of Covariance
Comparison: Change From Baseline at Week 390% CI: [-0.2536, 0.0274]Longitudinal Analysis of Covariance
Comparison: Change From Baseline at Week 490% CI: [-0.1971, 0.0812]Longitudinal Analysis of Covariance
Comparison: Change From Baseline Over Week 1 to 490% CI: [-0.2081, 0.0406]Longitudinal Analysis of Covariance
Secondary
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6)
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration.
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Change at Week 1 | 0.134 liters | Standard Deviation 0.3782 |
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Change at Week 3 | 0.264 liters | Standard Deviation 0.3149 |
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Change at Week 2 | 0.221 liters | Standard Deviation 0.3603 |
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Change at Week 4 | 0.178 liters | Standard Deviation 0.2986 |
| Placebo Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Baseline | 3.175 liters | Standard Deviation 0.7707 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Change at Week 4 | 0.106 liters | Standard Deviation 0.2664 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Baseline | 3.150 liters | Standard Deviation 0.7546 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Change at Week 1 | 0.078 liters | Standard Deviation 0.2401 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Change at Week 2 | 0.072 liters | Standard Deviation 0.1922 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) | Change at Week 3 | 0.069 liters | Standard Deviation 0.2569 |
Secondary
Change From Baseline in Forced Vital Capacity (FVC)
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Change at Week 1 | 0.140 liters | Standard Deviation 0.3866 |
| Placebo Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Change at Week 3 | 0.252 liters | Standard Deviation 0.3053 |
| Placebo Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Change at Week 2 | 0.243 liters | Standard Deviation 0.3813 |
| Placebo Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Change at Week 4 | 0.178 liters | Standard Deviation 0.3028 |
| Placebo Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.393 liters | Standard Deviation 0.8966 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Change at Week 4 | 0.080 liters | Standard Deviation 0.3136 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.384 liters | Standard Deviation 0.8958 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Change at Week 1 | 0.042 liters | Standard Deviation 0.2401 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Change at Week 2 | 0.066 liters | Standard Deviation 0.2321 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Forced Vital Capacity (FVC) | Change at Week 3 | 0.020 liters | Standard Deviation 0.2784 |
Secondary
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF)
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. The changes from baseline (CFB) at each week and over 4 weeks were analyzed.
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: CFB at Week 4 | 21.54 liters per minute | Standard Deviation 41.697 |
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: Baseline | 346.67 liters per minute | Standard Deviation 92.666 |
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: Baseline | 357.86 liters per minute | Standard Deviation 91.426 |
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: CFB at Week 2 | 22.25 liters per minute | Standard Deviation 38.822 |
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: CFB at Week 1 | 20.51 liters per minute | Standard Deviation 33.868 |
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: CFB at Week 2 | 20.70 liters per minute | Standard Deviation 29.127 |
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: CFB at Week 3 | 18.86 liters per minute | Standard Deviation 40.775 |
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: CFB at Week 3 | 22.55 liters per minute | Standard Deviation 35.234 |
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: CFB at Week 4 | 19.10 liters per minute | Standard Deviation 42.063 |
| Placebo Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: CFB at Week 1 | 17.42 liters per minute | Standard Deviation 31.1 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: CFB at Week 4 | 23.22 liters per minute | Standard Deviation 48.329 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: Baseline | 361.46 liters per minute | Standard Deviation 145.788 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: CFB at Week 1 | 22.25 liters per minute | Standard Deviation 41.585 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: CFB at Week 2 | 29.80 liters per minute | Standard Deviation 51.818 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: CFB at Week 3 | 23.55 liters per minute | Standard Deviation 42.129 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Morning PEF: CFB at Week 4 | 22.65 liters per minute | Standard Deviation 47.892 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: Baseline | 382.05 liters per minute | Standard Deviation 130.316 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: CFB at Week 1 | 20.14 liters per minute | Standard Deviation 43.925 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: CFB at Week 2 | 23.87 liters per minute | Standard Deviation 40.435 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) | Evening PEF: CFB at Week 3 | 17.74 liters per minute | Standard Deviation 44.378 |
Comparison: Morning PEF: CFB at Week 190% CI: [-10.76, 22.794]Longitudinal Analysis of Covariance
Comparison: Morning PEF: CFB at Week 290% CI: [-13.926, 27.108]Longitudinal Analysis of Covariance
Comparison: Morning PEF: CFB at Week 390% CI: [-18.644, 20.552]Longitudinal Analysis of Covariance
Comparison: Morning PEF: CFB at Week 490% CI: [-26.069, 17.333]Longitudinal Analysis of Covariance
Comparison: Morning PEF: CFB Averaged Over 4 Weeks90% CI: [-15.323, 19.92]Longitudinal Analysis of Covariance
Comparison: Evening PEF: CFB at Week 190% CI: [-17.248, 19.519]Longitudinal Analysis of Covariance
Comparison: Evening PEF: CFB at Week 290% CI: [-13.871, 19.54]Longitudinal Analysis of Covariance
Comparison: Evening PEF: CFB at Week 390% CI: [-27.933, 11.185]Longitudinal Analysis of Covariance
Comparison: Evening PEF: CFB at Week 490% CI: [-23.245, 22.356]Longitudinal Analysis of Covariance
Comparison: Evening PEF: CFB Averaged Over 4 Weeks90% CI: [-18.52, 16.096]Longitudinal Analysis of Covariance
Secondary
Number of Daily Puffs of Rescue Medication
The use of rescue bronchodilators (albuterol or levalbuterol) for symptomatic relief of asthma in a 24-hour period was recorded by the participant.
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Number of Daily Puffs of Rescue Medication | Week 1 | 1.51 puffs per day | Standard Deviation 1.254 |
| Placebo Twice Daily | Number of Daily Puffs of Rescue Medication | Week 3 | 1.48 puffs per day | Standard Deviation 1.391 |
| Placebo Twice Daily | Number of Daily Puffs of Rescue Medication | Week 2 | 1.51 puffs per day | Standard Deviation 1.431 |
| Placebo Twice Daily | Number of Daily Puffs of Rescue Medication | Week 4 | 1.34 puffs per day | Standard Deviation 1.385 |
| Placebo Twice Daily | Number of Daily Puffs of Rescue Medication | Baseline | 1.90 puffs per day | Standard Deviation 1.364 |
| PF-03715455 680 mcg Twice Daily | Number of Daily Puffs of Rescue Medication | Week 4 | 1.54 puffs per day | Standard Deviation 2.264 |
| PF-03715455 680 mcg Twice Daily | Number of Daily Puffs of Rescue Medication | Baseline | 1.96 puffs per day | Standard Deviation 1.628 |
| PF-03715455 680 mcg Twice Daily | Number of Daily Puffs of Rescue Medication | Week 1 | 1.74 puffs per day | Standard Deviation 2.164 |
| PF-03715455 680 mcg Twice Daily | Number of Daily Puffs of Rescue Medication | Week 2 | 1.07 puffs per day | Standard Deviation 1.494 |
| PF-03715455 680 mcg Twice Daily | Number of Daily Puffs of Rescue Medication | Week 3 | 1.37 puffs per day | Standard Deviation 1.772 |
Secondary
Number of Night Time Awakenings Per Week
The number of nocturnal awakenings due to asthma symptoms was recorded by the participant.
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Number of Night Time Awakenings Per Week | Week 1 | 1.34 night awakenings per week | Standard Deviation 2.101 |
| Placebo Twice Daily | Number of Night Time Awakenings Per Week | Week 3 | 0.89 night awakenings per week | Standard Deviation 1.657 |
| Placebo Twice Daily | Number of Night Time Awakenings Per Week | Week 2 | 1.39 night awakenings per week | Standard Deviation 1.99 |
| Placebo Twice Daily | Number of Night Time Awakenings Per Week | Week 4 | 1.04 night awakenings per week | Standard Deviation 1.869 |
| Placebo Twice Daily | Number of Night Time Awakenings Per Week | Baseline | 2.03 night awakenings per week | Standard Deviation 2.088 |
| PF-03715455 680 mcg Twice Daily | Number of Night Time Awakenings Per Week | Week 4 | 1.27 night awakenings per week | Standard Deviation 1.83 |
| PF-03715455 680 mcg Twice Daily | Number of Night Time Awakenings Per Week | Baseline | 1.40 night awakenings per week | Standard Deviation 1.925 |
| PF-03715455 680 mcg Twice Daily | Number of Night Time Awakenings Per Week | Week 1 | 1.38 night awakenings per week | Standard Deviation 2.21 |
| PF-03715455 680 mcg Twice Daily | Number of Night Time Awakenings Per Week | Week 2 | 1.43 night awakenings per week | Standard Deviation 2.251 |
| PF-03715455 680 mcg Twice Daily | Number of Night Time Awakenings Per Week | Week 3 | 1.66 night awakenings per week | Standard Deviation 2.431 |
Secondary
Time to Asthma Worsening Event
The time post randomization that the first asthma worsening event occurred (defined above).
Time frame: Baseline up to follow-up period (Week 16)
Population: The modified intent-to-treat (mITT) analysis set initially included all randomized participants who received at least 1 dose of PF-03715455 or placebo. Only 7 participants (4 in PF-03715455 and 3 in placebo) were included in the presented descriptive analysis, since other observations were censored by study termination.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Twice Daily | Time to Asthma Worsening Event | 58 days |
| PF-03715455 680 mcg Twice Daily | Time to Asthma Worsening Event | 19.5 days |