Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048022

Purpose

The primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Study participants will have a number of visits to a research site over a 4-month period.

Condition	Intervention	Phase
Asthma	Drug: Dual Integrin Antagonist	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Persistent asthma for more than 1 year
Currently receiving treatment with a stable dose of inhaled corticosteroids for more than 3 months
In good health as demonstrated by medical history and physical exam
Negative urine pregnancy test
Commitment to use two forms of effective contraception simultaneously throughout the study duration and for 1 month after discontinuing therapy

Exclusion Criteria:

Hospitalization for treatment of asthma and/or treatment with oral/injectable corticosteroids within 3 months before the start of the study
Undergoing allergy shots unless on a stable maintenance dose for 3 months before the start of the study
History of chronic pulmonary diseases other than asthma
Treatment of conditions other than asthma with oral corticosteroids within 1 month of the start of the study
Current tobacco usage
Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked)
History or evidence of drug or alcohol abuse
Diagnosis or evidence of an infectious illness within one month of Visit 1
Clinically significant diseases as assessed by the study doctor
Participation in another clinical study with an experimental drug within one month of start of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048022

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Locations

United States, California

San Diego, California, United States, 92120

San Diego, California, United States, 92103

Los Angeles, California, United States, 90025

Mission Viejo, California, United States, 92691

San Jose, California, United States, 95128

Walnut Creek, California, United States, 94598

Los Angeles, California, United States, 90095-1690

Huntington Beach, California, United States, 92647
United States, Colorado

Louisville, Colorado, United States, 80027

Denver, Colorado, United States, 80206

Denver, Colorado, United States, 80206

Boulder, Colorado, United States, 80304
United States, Florida

Tampa, Florida, United States, 33613

Tampa, Florida, United States, 33609

Tamarac, Florida, United States, 33321

Tallahassee, Florida, United States, 32308

Sarasota, Florida, United States, 34233
United States, Georgia

Atlanta, Georgia, United States, 30309
United States, Illinois

Chicago, Illinois, United States, 60611

Chicago, Illinois, United States, 60637

Normal, Illinois, United States, 61761
United States, Indiana

Indianapolis, Indiana, United States, 46208
United States, Iowa

Iowa City, Iowa, United States, 52240
United States, Kansas

Lenexa, Kansas, United States, 66219
United States, Louisiana

Metairie, Louisiana, United States, 70006
United States, Massachusetts

North Dartmouth, Massachusetts, United States, 02745
United States, Michigan

Ypsilanti, Michigan, United States, 48197
United States, Montana

Missoula, Montana, United States, 59804
United States, Nebraska

Omaha, Nebraska, United States, 68114
United States, Nevada

Las Vegas, Nevada, United States, 89104
United States, New Jersey

Teaneck, New Jersey, United States, 07666

Forked River, New Jersey, United States, 08731
United States, New York

Farmingdale, New York, United States, 11735

Rockville Centre, New York, United States, 11570

Rochester, New York, United States, 14618
United States, North Carolina

Asheville, North Carolina, United States, 28801
United States, Ohio

Cincinnati, Ohio, United States, 45231

Canton, Ohio, United States, 44718
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73120
United States, Oregon

Portland, Oregon, United States, 97213

Medford, Oregon, United States, 97504

Eugene, Oregon, United States, 97401
United States, Pennsylvania

Upland, Pennsylvania, United States, 19013

Philadelphia, Pennsylvania, United States, 19115

Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island

Providence, Rhode Island, United States, 02906
United States, South Carolina

Charleston, South Carolina, United States, 29425
United States, Texas

Dallas, Texas, United States, 75231

Dallas, Texas, United States, 75230

Sugar Land, Texas, United States, 77478

Austin, Texas, United States, 78750
United States, Utah

Murray, Utah, United States, 84107
United States, Vermont

South Burlington, Vermont, United States, 05403
United States, Virginia

Abingdon, Virginia, United States, 24210
United States, Washington

Tacoma, Washington, United States, 98405

Kirkland, Washington, United States, 98034

Seattle, Washington, United States, 98105

Bellingham, Washington, United States, 98225
United States, West Virginia

Morgantown, West Virginia, United States, 26505
United States, Wisconsin

Madison, Wisconsin, United States, 53792-9988
Puerto Rico

Ponce, Puerto Rico, 00732

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

Study ID Numbers:	BA16630
Study First Received:	October 24, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00048022 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 22, 2009