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



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

For Condition: Asthma
Status: No longer recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Persistent asthma for more than 1 year - Currently receiving treatment with a stable dose of inhaled corticosterods for more than 3 months - In good health as demonstrated by medical history and physical exam - Negative urine pregnancy test - Committment 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 1 month of Visit 1 - Clinically significant diseases as assessed by the study doctor - Participation in another clinical study with an experimental drug within 1 month of start of the study
Total Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:  BA16630; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048022

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