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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tacrolimus Inhalation Aerosol
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Asthma, Antiasthmatics, Antiasthmatic agents

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

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)

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 27, 2005
Last Updated
June 6, 2012
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00116103
Brief Title
A Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Asthma, Antiasthmatics, Antiasthmatic agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tacrolimus Inhalation Aerosol
Primary Outcome Measure Information:
Title
The primary outcome is the change in FEV1 from baseline to end-treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astellas Medical Monitor, MD
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45241
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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