Study in Patients With Asthma

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00215371
• Lead Sponsor: Dey

Brief Summary

The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2002-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Study Completion: 2005-11
• Status Verified: 2008-02
• Last Update Submitted: 2010-11-10
• Last Update Posted: 2010-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Require the regular use of an inhaled beta-2-selective adrenergic agent.
• No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.

Exclusion Criteria

• Active acute or chronic disorders of the respiratory system within one month prior to screening.
• Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history.
• Debilitating systemic and/or life-threatening diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Primary: The primary efficacy outcome is measure of lung function.

Secondary Outcome Measures

Name	Time	Method
Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, adverse event reporting,etc.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Medford, Oregon, United States