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

NCT ID: NCT00048009

Last Updated: 2017-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-25

Study Completion Date

2004-02-02

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Dual Integrin Antagonist

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Scottsdale, Arizona, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Palmdale, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Louisville, Colorado, United States

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Wheat Ridge, Colorado, United States

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Hartford, Connecticut, United States

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Tallahassee, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Normal, Illinois, United States

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River Forest, Illinois, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Lenexa, Kansas, United States

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Metairie, Louisiana, United States

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North Dartmouth, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Princeton, New Jersey, United States

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Teaneck, New Jersey, United States

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Farmingdale, New York, United States

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Rochester, New York, United States

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Rockville Centre, New York, United States

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Elizabeth City, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Easton, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Murray, Utah, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Wenatchee, Washington, United States

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Morgantown, West Virginia, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Adelaide, , Australia

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Brisbane, , Australia

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Melbourne, , Australia

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Perth, , Australia

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Sydney, , Australia

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Woodville, , Australia

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Vancouver, British Columbia, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Chihuahua City, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mérida, , Mexico

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México, , Mexico

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Monterrey, , Mexico

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Monterrey, , Mexico

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Puebla City, , Mexico

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Ponce, , Puerto Rico

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Countries

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United States Australia Canada Mexico Puerto Rico

Other Identifiers

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BA16631

Identifier Type: -

Identifier Source: org_study_id

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