An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
- Registration Number
- NCT02219048
- Lead Sponsor
- Pfizer
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 51
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-03715455 PF-03715455 PF-03715455 Placebo Placebo Matched blinded placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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.
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.
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.
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.
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.
Trial Locations
- Locations (28)
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
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Colorado Allergy and Asthma Centers, PC
🇺🇸Denver, Colorado, United States
Asthma and Allergy Associates, PC
🇺🇸Colorado Springs, Colorado, United States
University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit
🇺🇸Tampa, Florida, United States
Northeast Medical Research Associates, Inc.
🇺🇸North Dartmouth, Massachusetts, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
The Asthma and Allergy Center
🇺🇸Bellevue, Nebraska, United States
North Shore Long Island Jewish Health System
🇺🇸New Hyde Park, New York, United States
American Health Research
🇺🇸Charlotte, North Carolina, United States
Upstate Pharmaceutical Research
🇺🇸Greenville, South Carolina, United States
The Allergy & Asthma Clinic of Central Texas
🇺🇸Killeen, Texas, United States
University of Wisconsin School of Medicine & Public Health
🇺🇸Madison, Wisconsin, United States
Jonathan Corren MD, Inc.
🇺🇸Los Angeles, California, United States
California Research Medical Group, Inc
🇺🇸Fullerton, California, United States
California Allergy and Asthma Medical Group, Inc.
🇺🇸Los Angeles, California, United States
Allergy Associates Medical Group
🇺🇸San Diego, California, United States
Florida Pulmonary Research Institute, LLC
🇺🇸Winter Park, Florida, United States
Chesapeake Clinical Research, Inc.
🇺🇸Baltimore, Maryland, United States
Integrated Research Group, Incorporated
🇺🇸Riverside, California, United States
Bernstein Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
University of Pittsburgh Asthma Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Associated Specialists in Medicine, PC
🇺🇸Saint Louis, Missouri, United States
The Clinical Research Center, L.L.C.
🇺🇸Saint Louis, Missouri, United States