Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma - 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 NCT00048022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma
Official Title ^ICMJE
Brief Summary	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
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 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
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, Puerto Rico

Administrative Information
NCT ID ^ICMJE	NCT00048022
Responsible Party
Study ID Numbers ^ICMJE	BA16630
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