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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:
ClinicalTrials.gov Identifier:
NCT00116103
First Posted: June 28, 2005
Last Update Posted: June 7, 2012
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.
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
  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
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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)
  Contacts and Locations
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


  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

ClinicalTrials.gov Identifier: NCT00116103     History of Changes
Other Study ID Numbers: 04-0-213
First Submitted: June 27, 2005
First Posted: June 28, 2005
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:
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