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

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00048022
• Lead Sponsor: Hoffmann-La Roche

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

Not available

Study Timeline

• Study First Submitted: 2002-10-24
• Study First Submitted QC: 2002-10-24
• Study Start: 2002-10-25
• Study First Posted: 2002-10-25
• Primary Completion: 2004-02-02
• Study Completion: 2004-02-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified