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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
680 micrograms BID, Orally inhaled placebo for 12 weeks
680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks
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)
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)
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
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
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
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Pulmonary Associates, Pa
Phoenix, Arizona, United States
Little Rock Allergy & Asthma Clinical Research Center
Little Rock, Arkansas, United States
California Research Medical Group, Inc
Fullerton, California, United States
California Allergy and Asthma Medical Group, Inc.
Los Angeles, California, United States
Jonathan Corren MD, Inc.
Los Angeles, California, United States
Integrated Research Group, Incorporated
Riverside, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Allergy Associates Medical Group
San Diego, California, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
...and 18 more locations
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
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
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
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
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