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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00116103
First received: June 27, 2005
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: Tacrolimus Inhalation Aerosol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

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

Study Start Date: June 2005
Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116103

  Show 21 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Investigators
Study Director: Astellas Medical Monitor, MD Astellas Pharma US, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00116103     History of Changes
Other Study ID Numbers: 04-0-213
Study First Received: June 27, 2005
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Treatment Effectiveness
Treatment Efficacy
Investigational, Therapies
 Asthma
Antiasthmatics
Antiasthmatic agents

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Tacrolimus
Anti-Asthmatic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013