Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00425061
First received: January 18, 2007
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.


Condition Intervention Phase
Asthma
Biological: IMA-638
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 3 Dose Levels of IMA-638 in Subjects With Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The change from baseline to day 112 in AM peak expiratory flow rate (PEFR). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage change in pre-beta-agonist FEV1 (L) from baseline; Change in airway hyperreactivity (PC20); Change in ACQ-5 score; Rate of clinical exacerbation-asthma worsening requiring treatment with systemic steroids; Rescue beta-agonist use; FVC; FEF25 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 159
Study Start Date: February 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: IMA-638
SC Injection, 12 weeks
Experimental: 2 Biological: IMA-638
SC Injection, 12 weeks
Placebo Comparator: 3 Other: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425061

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35209
Montgomery, Alabama, United States, 36111
Montgomery, Alabama, United States, 36106
United States, Arizona
Phoenix, Arizona, United States, 85006
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Bakersfield, California, United States, 93301
Crescent City, California, United States, 95531
Fresno, California, United States, 93720
Long Beach, California, United States, 90808
Los Angeles, California, United States, 90025
Rancho Mirage, California, United States, 92270
Rolling Hills Estates, California, United States, 90274
San Diego, California, United States, 92101
San Diego, California, United States, 92120
San Jose, California, United States, 95117
San Jose, California, United States, 95128
Stockton, California, United States, 95207
Vista, California, United States, 92083
Walnut Creek, California, United States, 94598
United States, Colorado
Denver, Colorado, United States, 80206
Denver, Colorado, United States, 80230
United States, Connecticut
Waterbury, Connecticut, United States, 06708
United States, Florida
Miami, Florida, United States, 33176
Tampa, Florida, United States, 33613
Valrico, Florida, United States, 33594
West Palm Beach, Florida, United States, 33401
United States, Georgia
Albany, Georgia, United States, 31707
Atlanta, Georgia, United States, 30342
Lawrenceville, Georgia, United States, 30045
Savannah, Georgia, United States, 31406
United States, Illinois
River Forest, Illinois, United States, 60305
United States, Indiana
Fort Wayne, Indiana, United States, 46815
South Bend, Indiana, United States, 46617
United States, Iowa
Iowa City, Iowa, United States, 52240
United States, Kansas
Overland Park, Kansas, United States, 66210
United States, Kentucky
Crescent Springs, Kentucky, United States, 41017
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Gardner, Massachusetts, United States, 01440
Taunton, Massachusetts, United States, 02780
United States, Minnesota
Minneapolis, Minnesota, United States, 55402
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Missouri
Saint Louis, Missouri, United States, 63141
United States, Montana
Missoula, Montana, United States, 59808
United States, Nebraska
Omaha, Nebraska, United States, 68130
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Skillman, New Jersey, United States, 08558
Summit, New Jersey, United States, 07901
United States, New York
Albany, New York, United States, 12205
Bronx, New York, United States, 10461
New York, New York, United States, 10032
Rochester, New York, United States, 14618
United States, North Carolina
Asheville, North Carolina, United States, 28801
Raleigh, North Carolina, United States, 27607
Winston-Salem, North Carolina, United States, 27106
United States, Ohio
Canton, Ohio, United States, 44718
Cincinnati, Ohio, United States, 45231
Cincinnati, Ohio, United States, 45242
Sylvania, Ohio, United States, 43560
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Eugene, Oregon, United States, 97401
Lake Oswego, Oregon, United States, 97035
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97213
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18020
Philadelphia, Pennsylvania, United States, 19115
Pittsburgh, Pennsylvania, United States, 15241
Sellersville, Pennsylvania, United States, 18960
Upland, Pennsylvania, United States, 19013
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, South Carolina
Greenville, South Carolina, United States, 29607
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
Knoxville, Tennessee, United States, 37909
United States, Texas
Austin, Texas, United States, 78759
EL Paso, Texas, United States, 79925
Friendswood, Texas, United States, 77546
Houston, Texas, United States, 77070
Houston, Texas, United States, 77074
Houston, Texas, United States, 77054
Killeen, Texas, United States, 76542
San Antonio, Texas, United States, 78229
United States, Vermont
South Burlington, Vermont, United States, 05403
United States, Virginia
Richmond, Virginia, United States, 23229
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Milwaukee, Wisconsin, United States, 53209
Canada, Alberta
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Saint John, New Brunswick, Canada, E2M 3W5
Canada, Nova Scotia
Sydney, Nova Scotia, Canada, B1M 0A1
Canada, Ontario
Hamilton, Ontario, Canada, L8N 3Z5
Mississauga, Ontario, Canada, L5A 3V4
Niagara Falls, Ontario, Canada, L2G 1J4
Ottawa, Ontario, Canada, K1Y 4G2
Toronto, Ontario, Canada, M6H 3M2
Canada, Quebec
Longueuil, Quebec, Canada, J4N 1E1
Montréal, Quebec, Canada, H2L 2W5
Montréal, Quebec, Canada, H4J 1C5
Sainte-Foy, Quebec, Canada, G1V 4G5
Trois-Rivières, Quebec, Canada, G8T 7A1
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00425061     History of Changes
Other Study ID Numbers: 3174K1-201, B2421007
Study First Received: January 18, 2007
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014