Clinical trial NCT02219048: An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Staged withdrawal of background therapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-08-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Asthma Worsening Events
timeFrame: Baseline up to follow-up period (Week 16)
Secondary outcomes:
measure: Time to Asthma Worsening Event
timeFrame: Baseline up to follow-up period (Week 16)
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
measure: Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
measure: Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6)
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
measure: Change From Baseline in Asthma Symptom Scores
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
measure: Number of Night Time Awakenings Per Week
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
measure: Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF)
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
measure: Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
measure: Number of Daily Puffs of Rescue Medication
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates, Pa
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma Clinical Research Center
state: Arkansas
city: Fullerton
country: United States
facility: California Research Medical Group, Inc
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: Jonathan Corren MD, Inc.
state: California
city: Riverside
country: United States
facility: Integrated Research Group, Incorporated
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, PC
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Tampa
country: United States
facility: University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Baltimore
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Associated Specialists in Medicine, PC
state: Missouri
city: Saint Louis
country: United States
facility: The Clinical Research Center, L.L.C.
state: Missouri
city: Bellevue
country: United States
facility: The Asthma and Allergy Center
state: Nebraska
city: New Hyde Park
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Asthma Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Killeen
country: United States
facility: The Allergy & Asthma Clinic of Central Texas
state: Texas
city: Madison
country: United States
facility: University of Wisconsin School of Medicine & Public Health
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: