Study in Patients With Asthma

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00215410
• Lead Sponsor: Dey

Brief Summary

The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.

Detailed Description

Not available

Study Timeline

• Primary Completion: 2003-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Study Completion: 2005-10
• Status Verified: 2008-02
• Last Update Submitted: 2010-11-10
• Last Update Posted: 2010-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Children with a history of asthma
• Written guardian approval

Exclusion Criteria

• Current or recent asthma exacerbation, requiring hospitalization
• History of smoking
• Debilitating or systemic and/or life-threatening diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Measure of lung function

Secondary Outcome Measures

Name	Time	Method
Change in lung function, as well as vital signs
Physical Exam results, AE reporting, etc

Trial Locations

Locations (1)

Research Site; 🇺🇸 Houston, Texas, United States