Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048009

Purpose

The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to be used in future studies, assess the efficacy and safety, and the anti-inflammatory action of the test drug in the treatment of asthmatic patients who are not currently receiving chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical research sites in the US, Mexico, and Canada. Study participants will have a number of visits to a research site over approximately 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 one year
Current treatment for asthma with short acting inhaled beta 2 agonists (such as albuterol) only
In good health ad 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 one month after discontinuing therapy

Exclusion Criteria:

Asthma necessitating treatment with inhaled corticosteroids for at least one month before the start of the study
History of severe asthma necessitating the use of oral/injectable corticosteroids within the last 2 months and/and or two bursts in the last year
Undergoing allergy shots unless on a stable maintenance dose for three 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 one month of the start of the study
Current tobacco use
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: NCT00048009

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Locations

United States, Arizona

Scottsdale, Arizona, United States, 85251
United States, California

San Diego, California, United States, 92120

San Diego, California, United States, 92103

San Diego, California, United States, 92123

Los Angeles, California, United States, 90025

Long Beach, California, United States, 90806

San Jose, California, United States, 95128

Walnut Creek, California, United States, 94598

Huntington Beach, California, United States, 92647

Palmdale, California, United States, 93551

Los Angeles, California, United States, 90095-1690
United States, Colorado

Louisville, Colorado, United States, 80027

Denver, Colorado, United States, 80206

Denver, Colorado, United States, 80230

Wheat Ridge, Colorado, United States, 80033
United States, Connecticut

Hartford, Connecticut, United States, 06106
United States, Florida

Tampa, Florida, United States, 33613

Tampa, Florida, United States, 33609

Tamarac, Florida, United States, 33321

Tallahassee, Florida, United States, 32308
United States, Georgia

Atlanta, Georgia, United States, 30309

Savannah, Georgia, United States, 31406
United States, Illinois

Chicago, Illinois, United States, 60637-1470

Normal, Illinois, United States, 61761

River Forest, Illinois, United States, 60305
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, Minnesota

Minneapolis, Minnesota, United States, 55402
United States, Missouri

St. Louis, Missouri, United States, 63141
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

Princeton, New Jersey, United States, 08540

Cherry Hill, New Jersey, United States, 08003
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

Elizabeth City, North Carolina, United States, 27909
United States, Ohio

Cincinnati, Ohio, United States, 45231

Canton, Ohio, United States, 44718
United States, Oregon

Portland, Oregon, United States, 97213

Medford, Oregon, United States, 97504
United States, Pennsylvania

Upland, Pennsylvania, United States, 19013

Philadelphia, Pennsylvania, United States, 19115

Philadelphia, Pennsylvania, United States, 19140

Easton, Pennsylvania, United States, 18045
United States, Rhode Island

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

Charleston, South Carolina, United States, 29425

Charleston, South Carolina, United States, 29407
United States, Texas

Dallas, Texas, United States, 75231

Dallas, Texas, United States, 75240

Sugar Land, Texas, United States, 77478

Austin, Texas, United States, 78750

San Antonio, Texas, United States, 78229

El Paso, Texas, United States, 79925
United States, Utah

Murray, Utah, United States, 84107
United States, Washington

Tacoma, Washington, United States, 98405

Kirkland, Washington, United States, 98034

Seattle, Washington, United States, 98105

Spokane, Washington, United States, 99202

Wenatchee, Washington, United States, 98801
United States, West Virginia

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

Madison, Wisconsin, United States, 53792-9988

Milwaukee, Wisconsin, United States, 53209
Australia

Sydney, Australia, 2139

Melbourne, Australia, 3050

Adelaide, Australia, 5000

Perth, Australia, 6009

Woodville, Australia, 5011

Brisbane, Australia, 4102
Canada, British Columbia

Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario

Toronto, Ontario, Canada, M6H 3M2

Toronto, Ontario, Canada, M5S 2A5

Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec

Montreal, Quebec, Canada, H4J 1C5

Quebec City, Quebec, Canada, O1V 4G5
Mexico

Puebla, Mexico, 72000

Mexico City, Mexico, 14050

Mexico City, Mexico, 06700

Monterrey, Mexico, 64000

Monterrey, Mexico, 64710

Mexico DF, Mexico, 06720

Guadalajara, Mexico, 44600

Mexico, Mexico, 14080

Chihuahua, Mexico, 31000

Merida, Mexico
Puerto Rico

Ponce, Puerto Rico, 00732

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

Study ID Numbers:	BA16631
Study First Received:	October 24, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00048009 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 30, 2009