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

NCT ID: NCT00048022

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 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.

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 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
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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Huntington Beach, California, United States

Site Status

Los Angeles, California, United States

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Los Angeles, California, United States

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Mission Viejo, 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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Boulder, Colorado, United States

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Denver, Colorado, United States

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Louisville, Colorado, United States

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Sarasota, Florida, 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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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Normal, 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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Ypsilanti, Michigan, 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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Forked River, 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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Asheville, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, 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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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Sugar Land, Texas, United States

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Murray, Utah, United States

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South Burlington, Vermont, United States

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Abingdon, Virginia, United States

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Bellingham, Washington, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Morgantown, West Virginia, United States

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Madison, Wisconsin, United States

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Ponce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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BA16630

Identifier Type: -

Identifier Source: org_study_id

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