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

Tracking Information
First Received Date ^ICMJE	October 24, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00048009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids
Official Title ^ICMJE
Brief Summary	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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Drug: Dual Integrin Antagonist
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Canada, Mexico, Puerto Rico

Administrative Information
NCT ID ^ICMJE	NCT00048009
Responsible Party
Study ID Numbers ^ICMJE	BA16631
Study Sponsor ^ICMJE	Hoffmann-La Roche
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Hoffmann-La Roche
Verification Date	May 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP