Back to resultsAn Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
Primary Purpose
Asthma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
PF-03715455
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Staged withdrawal of background therapy
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.
Sites / Locations
- Clinical Research Center of Alabama
- Pulmonary Associates, Pa
- Little Rock Allergy & Asthma Clinical Research Center
- California Research Medical Group, Inc
- California Allergy and Asthma Medical Group, Inc.
- Jonathan Corren MD, Inc.
- Integrated Research Group, Incorporated
- Peninsula Research Associates
- Allergy Associates Medical Group
- Asthma and Allergy Associates, PC
- Colorado Allergy and Asthma Centers, PC
- University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit
- Florida Pulmonary Research Institute, LLC
- Chesapeake Clinical Research, Inc.
- Northeast Medical Research Associates, Inc.
- Clinical Research Institute
- Washington University School of Medicine
- Associated Specialists in Medicine, PC
- The Clinical Research Center, L.L.C.
- The Asthma and Allergy Center
- North Shore Long Island Jewish Health System
- American Health Research
- Wake Forest University School of Medicine
- Bernstein Clinical Research Center
- University of Pittsburgh Asthma Institute
- Upstate Pharmaceutical Research
- The Allergy & Asthma Clinic of Central Texas
- University of Wisconsin School of Medicine & Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
PF-03715455
Arm Description
Matched blinded placebo
PF-03715455
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to Asthma Worsening Event
The time post randomization that the first asthma worsening event occurred (defined above).
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.
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.
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.
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
Number of Night Time Awakenings Per Week
The number of nocturnal awakenings due to asthma symptoms was recorded by the participant.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02219048
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study
Study Start Date
November 2014 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Staged withdrawal of background therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched blinded placebo
Arm Title
PF-03715455
Arm Type
Experimental
Arm Description
PF-03715455
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
680 micrograms BID, Orally inhaled placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
PF-03715455
Intervention Description
680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Asthma Worsening Events
Description
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)
Secondary Outcome Measure Information:
Title
Time to Asthma Worsening Event
Description
The time post randomization that the first asthma worsening event occurred (defined above).
Time Frame
Baseline up to follow-up period (Week 16)
Title
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Description
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
Title
Change From Baseline in Forced Vital Capacity (FVC)
Description
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
Title
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6)
Description
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
Title
Change From Baseline in Asthma Symptom Scores
Description
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
Title
Number of Night Time Awakenings Per Week
Description
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
Title
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF)
Description
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
Title
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4
Description
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
Title
Number of Daily Puffs of Rescue Medication
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Pulmonary Associates, Pa
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Little Rock Allergy & Asthma Clinical Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-4565
Country
United States
Facility Name
California Research Medical Group, Inc
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
California Allergy and Asthma Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Jonathan Corren MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Integrated Research Group, Incorporated
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Peninsula Research Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Allergy Associates Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Asthma and Allergy Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Colorado Allergy and Asthma Centers, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Florida Pulmonary Research Institute, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Northeast Medical Research Associates, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Associated Specialists in Medicine, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
The Clinical Research Center, L.L.C.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
The Asthma and Allergy Center
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
North Shore Long Island Jewish Health System
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Bernstein Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
University of Pittsburgh Asthma Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Upstate Pharmaceutical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
The Allergy & Asthma Clinic of Central Texas
City
Killeen
State/Province
Texas
ZIP/Postal Code
76542
Country
United States
Facility Name
University of Wisconsin School of Medicine & Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9111007&StudyName=An%20Evaluation%20Of%20PF-03715455%20In%20Moderate%20To%20Severe%20Uncontrolled%20Asthma
Description
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Learn more about this trial
An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
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