Study Stopped
The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study
An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-03715455 ADMINISTERED TWICE DAILY BY INHALATION FOR 12 WEEKS IN SUBJECTS WITH PERSISTENT MODERATE TO SEVERE ASTHMA WHO REMAIN UNCONTROLLED DESPITE TREATMENT WITH INHALED CORTICOSTEROIDS (ICS) AND LONG-ACTING BETA2 AGONISTS (LABA)
2 other identifiers
interventional
51
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started Nov 2014
Shorter than P25 for phase_2 asthma
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2014
CompletedFirst Posted
Study publicly available on registry
August 18, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
June 12, 2019
CompletedJune 12, 2019
May 1, 2019
6 months
August 14, 2014
April 12, 2016
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline up to follow-up period (Week 16)
Secondary Outcomes (9)
Time to Asthma Worsening Event
Baseline up to follow-up period (Week 16)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Forced Vital Capacity (FVC)
Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6)
Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Asthma Symptom Scores
Baseline, Week 1, Week 2, Week 3, and Week 4
- +4 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORMatched blinded placebo
PF-03715455
EXPERIMENTALPF-03715455
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (28)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Pulmonary Associates, Pa
Phoenix, Arizona, 85006, United States
Little Rock Allergy & Asthma Clinical Research Center
Little Rock, Arkansas, 72205-4565, United States
California Research Medical Group, Inc
Fullerton, California, 92835, United States
California Allergy and Asthma Medical Group, Inc.
Los Angeles, California, 90025, United States
Jonathan Corren MD, Inc.
Los Angeles, California, 90025, United States
Integrated Research Group, Incorporated
Riverside, California, 92506, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Allergy Associates Medical Group
San Diego, California, 92108, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907, United States
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230, United States
University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, 33613, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789, United States
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, 21236, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Associated Specialists in Medicine, PC
St Louis, Missouri, 63141, United States
The Clinical Research Center, L.L.C.
St Louis, Missouri, 63141, United States
The Asthma and Allergy Center
Bellevue, Nebraska, 68123, United States
North Shore Long Island Jewish Health System
New Hyde Park, New York, 11040, United States
American Health Research
Charlotte, North Carolina, 28277, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27103, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231, United States
University of Pittsburgh Asthma Institute
Pittsburgh, Pennsylvania, 15213, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615, United States
The Allergy & Asthma Clinic of Central Texas
Killeen, Texas, 76542, United States
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early due to portfolio prioritization. Most participants observations of time to asthma worsening event were censored by the study termination.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2014
First Posted
August 18, 2014
Study Start
November 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 12, 2019
Results First Posted
June 12, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.