An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma

Asthma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02219048
• Other study ID #: A9111007
• Secondary ID: INHALED P38I AST
• Status: Terminated
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Placebo
680 micrograms BID, Orally inhaled placebo for 12 weeks
• PF-03715455
680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks

Locations

Country	Name	City	State
United States	Chesapeake Clinical Research, Inc.	Baltimore	Maryland
United States	The Asthma and Allergy Center	Bellevue	Nebraska
United States	Clinical Research Center of Alabama	Birmingham	Alabama
United States	American Health Research	Charlotte	North Carolina
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	Asthma and Allergy Associates, PC	Colorado Springs	Colorado
United States	Colorado Allergy and Asthma Centers, PC	Denver	Colorado
United States	California Research Medical Group, Inc	Fullerton	California
United States	Upstate Pharmaceutical Research	Greenville	South Carolina
United States	The Allergy & Asthma Clinic of Central Texas	Killeen	Texas
United States	Little Rock Allergy & Asthma Clinical Research Center	Little Rock	Arkansas
United States	California Allergy and Asthma Medical Group, Inc.	Los Angeles	California
United States	Jonathan Corren MD, Inc.	Los Angeles	California
United States	University of Wisconsin School of Medicine & Public Health	Madison	Wisconsin
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	North Shore Long Island Jewish Health System	New Hyde Park	New York
United States	Northeast Medical Research Associates, Inc.	North Dartmouth	Massachusetts
United States	Pulmonary Associates, Pa	Phoenix	Arizona
United States	University of Pittsburgh Asthma Institute	Pittsburgh	Pennsylvania
United States	Integrated Research Group, Incorporated	Riverside	California
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Associated Specialists in Medicine, PC	Saint Louis	Missouri
United States	The Clinical Research Center, L.L.C.	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Allergy Associates Medical Group	San Diego	California
United States	University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit	Tampa	Florida
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina
United States	Florida Pulmonary Research Institute, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline up to follow-up period (Week 16)
Secondary	Time to Asthma Worsening Event	The time post randomization that the first asthma worsening event occurred (defined above).	Baseline up to follow-up period (Week 16)
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.	Baseline, Week 1, Week 2, Week 3, and Week 4
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.	Baseline, Week 1, Week 2, Week 3, and Week 4
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.	Baseline, Week 1, Week 2, Week 3, and Week 4
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	Baseline, Week 1, Week 2, Week 3, and Week 4
Secondary	Number of Night Time Awakenings Per Week	The number of nocturnal awakenings due to asthma symptoms was recorded by the participant.	Baseline, Week 1, Week 2, Week 3, and Week 4
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.	Baseline, Week 1, Week 2, Week 3, and Week 4
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.	Baseline, Week 1, Week 2, Week 3, and Week 4
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.	Baseline, Week 1, Week 2, Week 3, and Week 4

External Links

•   To obtain contact information for a study center near you, click here.