Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
- Conditions
- Asthma
- Interventions
- Biological: IMA-638Other: placebo
- Registration Number
- NCT00425061
- Lead Sponsor
- Pfizer
- Brief Summary
Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg.
- History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study.
- FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 IMA-638 - 1 IMA-638 - 3 placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3 Baseline, Day 112 The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1 Baseline, Day 112 The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.
- Secondary Outcome Measures
Name Time Method Mean Number of Puffs of Rescue Medication Used - Stage 2/3 Day 8, 28, 56, 84, 89, 91, 94, 98, 112 The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1 Baseline, Day 8, 28, 56, 84, 112 ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. 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 less than or equal to (=\<) 0.75 indicate well-controlled asthma, scores between 0.76 and less than (\<) 1.5 indicate partly controlled asthma, and a score greater than or equal to (\>=) 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1 Baseline, Day 8, 28, 56, 84, 112 FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3 Baseline, Day 8, 28, 56, 84, 112 FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.
Change From Baseline in Airway Hyper-reactivity at Day 28 and 112 Baseline, Day 28, 112 Airway hyper-reactivity was assessed using provocative concentration 20 (PC20). PC20 was the concentration of methacholine at which participants had 20 percent (%) decrease in FEV1. Results for PC20 were summarized together for all participants who received any dose of IMA-638 and for all participants who received placebo during any stage of the study as per investigator's discretion.
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3 Baseline, Day 8, 28, 56, 84, 112 ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. 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 \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Forced Vital Capacity (FVC) - Stage 1 Baseline, Day 8, 28, 56, 84, 112 FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3 Baseline, Day 8, 28, 56, 84, 112 FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Blood Eosinophils Levels - Stage 1 Baseline, Day 8, 28, 56, 84, 112 Serum Interleukin-13 (IL-13) Level - Stage 1 Baseline, Day 8, 28, 56, 84, 112 Serum Interleukin-13 (IL-13) Level - Stage 2/3 Baseline, Day 8, 28, 56, 84, 112 Forced Vital Capacity (FVC) - Stage 2/3 Baseline, Day 8, 28, 56, 84, 112 FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1 Baseline, Day 8, 28, 56, 84, 112 FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Blood Eosinophils Levels - Stage 2/3 Baseline, Day 8, 28, 56, 84, 112 Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1 Baseline up to Day 112 Mean Number of Puffs of Rescue Medication Used - Stage 1 Day 8, 28, 56, 84, 89, 91, 94, 98, 112 The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3 Baseline up to Day 112 Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1 Baseline, Day 28, 56, 84, 112 Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3 Baseline, Day 28, 56, 84, 112 Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Trial Locations
- Locations (80)
Allergy and Clinical Immunology
🇺🇸Pittsburgh, Pennsylvania, United States
Allergy and Asthma Care Center of Southern California
🇺🇸Long Beach, California, United States
Alabama Allergy & Asthma Clinic
🇺🇸Montgomery, Alabama, United States
Allergy & Respiratory Center
🇺🇸Canton, Ohio, United States
Regional Allergy and Asthma Consultants, P.A.
🇺🇸Asheville, North Carolina, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Alpha Medical Research Inc.
🇨🇦Mississauga, Ontario, Canada
Allergy and Asthma Research Group
🇺🇸Eugene, Oregon, United States
Allergy and Asthma Associates
🇺🇸Houston, Texas, United States
Clinical Trials North Houston
🇺🇸Houston, Texas, United States
Allergy and Asthma Assoc
🇺🇸Las Vegas, Nevada, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
Waterbury Pulmonary Associates
🇺🇸Waterbury, Connecticut, United States
Brandon-Valico Center for Allergy & Asthma Research, LLC
🇺🇸Valrico, Florida, United States
Roberson Allergy & Asthma
🇺🇸West Palm Beach, Florida, United States
Clinical Research Specialists
🇺🇸Metairie, Louisiana, United States
Allergy and Arthritis Family
🇺🇸Gardner, Massachusetts, United States
Center for Clinical Research
🇺🇸Taunton, Massachusetts, United States
Mississippi Asthma and Allergy Clinic, P.A.
🇺🇸Jackson, Mississippi, United States
Princeton Center for Clinical Research
🇺🇸Skillman, New Jersey, United States
Montana Medical Research, Inc
🇺🇸Missoula, Montana, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
Allergy Asthma and Immunology
🇺🇸San Antonio, Texas, United States
College Park Family Care Center
🇺🇸Overland Park, Kansas, United States
Kansas City Allergy & Asthma
🇺🇸Overland Park, Kansas, United States
Pacific Coast Allergy
🇺🇸Crescent City, California, United States
ABM Research Center
🇺🇸Fresno, California, United States
Allergy Medical Clinic
🇺🇸Los Angeles, California, United States
Advances in Medicine
🇺🇸Rancho Mirage, California, United States
Penisula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Allergy Associates Medical Group, Inc.
🇺🇸San Diego, California, United States
Allergy & Asthma Assoc of Santa Clara Valley Research Ctr
🇺🇸San Jose, California, United States
Aero Allergy Research Labs of Savannah, Inc. 505 Eisenhower
🇺🇸Savannah, Georgia, United States
Fort Wayne Medical Institute
🇺🇸Fort Wayne, Indiana, United States
Bensch Research Associates
🇺🇸Stockton, California, United States
Allergy and Immunology Medical Group
🇺🇸Vista, California, United States
Abraham Research, PLLC
🇺🇸Crescent Springs, Kentucky, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
The Clinical Research Center LLC
🇺🇸St Louis, Missouri, United States
Midwest Clinical Research LLC
🇺🇸St. Louis, Missouri, United States
Pulmonary and Allergy Associates
🇺🇸Sellersville, Pennsylvania, United States
AAPRI Clinical Research Institute
🇺🇸Lincoln, Rhode Island, United States
Pulmonary & Critical Care Services, P.C.5 Palisades Dr., Su
🇺🇸Albany, New York, United States
Allergy and Asthma Research Center of El Paso
🇺🇸El Paso, Texas, United States
Toledo Center for Clinial Researcch
🇺🇸Sylvania, Ohio, United States
Valley Clinical Research Center
🇺🇸Bethlehem, Pennsylvania, United States
Allergy & Asthma Research of New Jersey
🇺🇸Philadelphia, Pennsylvania, United States
Family Center for Asthma & Allergic Diseases
🇺🇸Friendswood, Texas, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
The Allergy and Asthma Clinic of Central Texas
🇺🇸Killeen, Texas, United States
Alabama Allergy and Asthma Center
🇺🇸Birmingham, Alabama, United States
Allergy, Asthma & Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
National Jewish Medical & Research Center
🇺🇸Denver, Colorado, United States
Colorado Allergy and Asthma Centers
🇺🇸Denver, Colorado, United States
Allergy Associates Research Center
🇺🇸Portland, Oregon, United States
Midwest Allergy and Asthma Clinic
🇺🇸Omaha, Nebraska, United States
Auroroa Health Care, Inc.
🇺🇸Milwaukee, Wisconsin, United States
Clinical Research Institute of Southern Oregon
🇺🇸Medford, Oregon, United States
Little Rock Allergy & Asthma
🇺🇸Little Rock, Arkansas, United States
Allergy and Asthma Research Centre
🇨🇦Ottawa, Ontario, Canada
East Tennessee Center for Clinical Research
🇺🇸Knoxville, Tennessee, United States
Alexander Medical Innovations Inc.
🇨🇦Niagara Falls, Ontario, Canada
Allergic Disease and Asthma Center Research, PA
🇺🇸Greenville, South Carolina, United States
CIC Mauricie Inc.
🇨🇦Trois-Rivieres, Quebec, Canada
Recherche Invascor Inc
🇨🇦Longueuil, Quebec, Canada
Timber Lane Allergy and Asthma Research LLC
🇺🇸South Burlington, Vermont, United States
Hopital du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
AAC Research, PC
🇺🇸Mount Pleasant, South Carolina, United States
Allergy, Asthma and Dermatology Research Center, LLC 3975 Me
🇺🇸Lake Oswego, Oregon, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Lovelace Scientific Resources
🇺🇸Austin, Texas, United States
Virginia Adult & Pediatric Allergy & Asthma, P.C.
🇺🇸Richmond, Virginia, United States
University of Wisconsin Medical School
🇺🇸Madison, Wisconsin, United States
San Jose Clinical Research, Inc.
🇺🇸San Jose, California, United States
Allergy & Asthma Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Georgia Pollens CRC, Inc.
🇺🇸Albany, Georgia, United States
DataQuest Medical Research
🇺🇸Lawrenceville, Georgia, United States
Allergy and Asthma Center of Chicago
🇺🇸River Forest, Illinois, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States