A Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00116103
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.

Detailed Description

The purpose of this randomized, double-blind, placebo-controlled, parallel-group, multi-center designed trial is to determine the safety and efficacy of tacrolimus inhalation aerosol in subjects with persistent asthma.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-06-27
• Study First Submitted QC: 2005-06-27
• Study First Posted: 2005-06-28
• Study Completion: 2006-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

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

Inclusion Criteria

• Diagnosis of persistent asthma for at least 6 months
• Require use of beta-agonists at least four times per week

Exclusion Criteria

• Diagnosis of chronic obstructive pulmonary disease (COPD)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change in FEV1 from baseline to end-treatment.