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

NCT ID: NCT00425061

Last Updated: 2015-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

IMA-638

Intervention Type BIOLOGICAL

SC Injection, 12 weeks

2

Group Type EXPERIMENTAL

IMA-638

Intervention Type BIOLOGICAL

SC Injection, 12 weeks

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

Interventions

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IMA-638

SC Injection, 12 weeks

Intervention Type BIOLOGICAL

IMA-638

SC Injection, 12 weeks

Intervention Type BIOLOGICAL

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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%.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Alabama Allergy and Asthma Center

Birmingham, Alabama, United States

Site Status

Alabama Allergy & Asthma Clinic

Montgomery, Alabama, United States

Site Status

Little Rock Allergy & Asthma

Little Rock, Arkansas, United States

Site Status

Pacific Coast Allergy

Crescent City, California, United States

Site Status

ABM Research Center

Fresno, California, United States

Site Status

Allergy and Asthma Care Center of Southern California

Long Beach, California, United States

Site Status

Allergy Medical Clinic

Los Angeles, California, United States

Site Status

Advances in Medicine

Rancho Mirage, California, United States

Site Status

Penisula Research Associates

Rolling Hills Estates, California, United States

Site Status

Sharp Rees-Stealy Medical Group

San Diego, California, United States

Site Status

Allergy Associates Medical Group, Inc.

San Diego, California, United States

Site Status

Allergy & Asthma Assoc of Santa Clara Valley Research Ctr

San Jose, California, United States

Site Status

San Jose Clinical Research, Inc.

San Jose, California, United States

Site Status

Bensch Research Associates

Stockton, California, United States

Site Status

Allergy and Immunology Medical Group

Vista, California, United States

Site Status

Allergy & Asthma Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

National Jewish Medical & Research Center

Denver, Colorado, United States

Site Status

Colorado Allergy and Asthma Centers

Denver, Colorado, United States

Site Status

Waterbury Pulmonary Associates

Waterbury, Connecticut, United States

Site Status

Brandon-Valico Center for Allergy & Asthma Research, LLC

Valrico, Florida, United States

Site Status

Roberson Allergy & Asthma

West Palm Beach, Florida, United States

Site Status

Georgia Pollens CRC, Inc.

Albany, Georgia, United States

Site Status

DataQuest Medical Research

Lawrenceville, Georgia, United States

Site Status

Aero Allergy Research Labs of Savannah, Inc. 505 Eisenhower

Savannah, Georgia, United States

Site Status

Allergy and Asthma Center of Chicago

River Forest, Illinois, United States

Site Status

Fort Wayne Medical Institute

Fort Wayne, Indiana, United States

Site Status

South Bend Clinic

South Bend, Indiana, United States

Site Status

College Park Family Care Center

Overland Park, Kansas, United States

Site Status

Kansas City Allergy & Asthma

Overland Park, Kansas, United States

Site Status

Abraham Research, PLLC

Crescent Springs, Kentucky, United States

Site Status

Clinical Research Specialists

Metairie, Louisiana, United States

Site Status

Allergy and Arthritis Family

Gardner, Massachusetts, United States

Site Status

Center for Clinical Research

Taunton, Massachusetts, United States

Site Status

Clinical Research Institute

Minneapolis, Minnesota, United States

Site Status

Mississippi Asthma and Allergy Clinic, P.A.

Jackson, Mississippi, United States

Site Status

Midwest Clinical Research LLC

St Louis, Missouri, United States

Site Status

The Clinical Research Center LLC

St Louis, Missouri, United States

Site Status

Montana Medical Research, Inc

Missoula, Montana, United States

Site Status

Midwest Allergy and Asthma Clinic

Omaha, Nebraska, United States

Site Status

Allergy and Asthma Assoc

Las Vegas, Nevada, United States

Site Status

Princeton Center for Clinical Research

Skillman, New Jersey, United States

Site Status

Pulmonary and Allergy Associates

Summit, New Jersey, United States

Site Status

Pulmonary & Critical Care Services, P.C.5 Palisades Dr., Su

Albany, New York, United States

Site Status

AAIR Research Center

Rochester, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Regional Allergy and Asthma Consultants, P.A.

Asheville, North Carolina, United States

Site Status

AAC Research, PC

Mt Pleasant, North Carolina, United States

Site Status

North Carolina Clinical Research

Raleigh, North Carolina, United States

Site Status

Allergy & Respiratory Center

Canton, Ohio, United States

Site Status

New Horizons Clinical Research

Cincinnati, Ohio, United States

Site Status

Toledo Center for Clinial Researcch

Sylvania, Ohio, United States

Site Status

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, United States

Site Status

Allergy and Asthma Research Group

Eugene, Oregon, United States

Site Status

Allergy, Asthma and Dermatology Research Center, LLC 3975 Me

Lake Oswego, Oregon, United States

Site Status

Clinical Research Institute of Southern Oregon

Medford, Oregon, United States

Site Status

Allergy Associates Research Center

Portland, Oregon, United States

Site Status

Valley Clinical Research Center

Bethlehem, Pennsylvania, United States

Site Status

Allergy & Asthma Research of New Jersey

Philadelphia, Pennsylvania, United States

Site Status

Allergy and Clinical Immunology

Pittsburgh, Pennsylvania, United States

Site Status

Pulmonary and Allergy Associates

Sellersville, Pennsylvania, United States

Site Status

AAPRI Clinical Research Institute

Lincoln, Rhode Island, United States

Site Status

Allergic Disease and Asthma Center Research, PA

Greenville, South Carolina, United States

Site Status

AAC Research, PC

Mt. Pleasant, South Carolina, United States

Site Status

East Tennessee Center for Clinical Research

Knoxville, Tennessee, United States

Site Status

Lovelace Scientific Resources

Austin, Texas, United States

Site Status

Allergy and Asthma Research Center of El Paso

El Paso, Texas, United States

Site Status

Family Center for Asthma & Allergic Diseases

Friendswood, Texas, United States

Site Status

Allergy and Asthma Associates

Houston, Texas, United States

Site Status

Clinical Trials North Houston

Houston, Texas, United States

Site Status

Clinical Trial Network

Houston, Texas, United States

Site Status

The Allergy and Asthma Clinic of Central Texas

Killeen, Texas, United States

Site Status

Allergy Asthma and Immunology

San Antonio, Texas, United States

Site Status

Timber Lane Allergy and Asthma Research LLC

South Burlington, Vermont, United States

Site Status

Virginia Adult & Pediatric Allergy & Asthma, P.C.

Richmond, Virginia, United States

Site Status

University of Wisconsin Medical School

Madison, Wisconsin, United States

Site Status

Auroroa Health Care, Inc.

Milwaukee, Wisconsin, United States

Site Status

Alpha Medical Research Inc.

Mississauga, Ontario, Canada

Site Status

Alexander Medical Innovations Inc.

Niagara Falls, Ontario, Canada

Site Status

Allergy and Asthma Research Centre

Ottawa, Ontario, Canada

Site Status

Recherche Invascor Inc

Longueuil, Quebec, Canada

Site Status

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Site Status

CIC Mauricie Inc.

Trois-Rivières, Quebec, Canada

Site Status

Countries

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United States Canada

Related Links

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Other Identifiers

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B2421007

Identifier Type: OTHER

Identifier Source: secondary_id

3174K1-201

Identifier Type: -

Identifier Source: org_study_id

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