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

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

MedlinePlus related topics:

Asthma

Drug Information available for:

Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Show 61 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

More Information

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

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases

Bronchial Diseases

ClinicalTrials.gov processed this record on November 20, 2008

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