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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00116103
Recruitment Status : Completed
First Posted : June 28, 2005
Last Update Posted : June 7, 2012
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Tacrolimus Inhalation Aerosol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2005
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Tacrolimus




Primary Outcome Measures :
  1. The primary outcome is the change in FEV1 from baseline to end-treatment.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116103


Locations
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United States, Arizona
Scottsdale, Arizona, United States, 85251
United States, California
Encinitas, California, United States, 92024
Los Angeles, California, United States, 90025
San Diego, California, United States, 92120
San Jose, California, United States, 95128
United States, Colorado
Denver, Colorado, United States, 80206
United States, Florida
Daytona Beach, Florida, United States, 32114
Miami, Florida, United States, 33176
United States, Idaho
Boise, Idaho, United States, 83704
United States, Illinois
River Forest, Illinois, United States, 60305
United States, Indiana
South Bend, Indiana, United States, 46617
United States, Missouri
St Louis, Missouri, United States, 63141
United States, Montana
Missoula, Montana, United States, 59804
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Ohio
Cincinnati, Ohio, United States, 45241
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73120
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, South Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
San Antonio, Texas, United States, 78229
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Investigators
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Study Director: Astellas Medical Monitor, MD Astellas Pharma US, Inc.

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ClinicalTrials.gov Identifier: NCT00116103    
Other Study ID Numbers: 04-0-213
First Posted: June 28, 2005    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012
Keywords provided by Astellas Pharma Inc:
Treatment Effectiveness
Treatment Efficacy
Investigational, Therapies
Asthma
Antiasthmatics
Antiasthmatic agents
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action