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

Show 91 Study Locations

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 09, 2009