A Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma
A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma
1 other identifier
interventional
N/A
1 country
21
Brief Summary
The purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2005
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 27, 2005
CompletedFirst Posted
Study publicly available on registry
June 28, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedJune 7, 2012
June 1, 2012
June 27, 2005
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome is the change in FEV1 from baseline to end-treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of persistent asthma for at least 6 months
- Require use of beta-agonists at least four times per week
You may not qualify if:
- Diagnosis of chronic obstructive pulmonary disease (COPD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (21)
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Encinitas, California, 92024, United States
Unknown Facility
Los Angeles, California, 90025, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
San Jose, California, 95128, United States
Unknown Facility
Denver, Colorado, 80206, United States
Unknown Facility
Daytona Beach, Florida, 32114, United States
Unknown Facility
Miami, Florida, 33176, United States
Unknown Facility
Boise, Idaho, 83704, United States
Unknown Facility
River Forest, Illinois, 60305, United States
Unknown Facility
South Bend, Indiana, 46617, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Missoula, Montana, 59804, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Cincinnati, Ohio, 45241, United States
Unknown Facility
Oklahoma City, Oklahoma, 73120, United States
Unknown Facility
Providence, Rhode Island, 02906, United States
Unknown Facility
Spartanburg, South Carolina, 29303, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Milwaukee, Wisconsin, 53209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Astellas Medical Monitor, MD
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 27, 2005
First Posted
June 28, 2005
Study Start
June 1, 2005
Study Completion
April 1, 2006
Last Updated
June 7, 2012
Record last verified: 2012-06