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

June 6, 2012 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Study Director: Astellas Medical Monitor, MD, Astellas Pharma US, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

June 27, 2005

First Submitted That Met QC Criteria

June 27, 2005

First Posted (Estimate)

June 28, 2005

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0-213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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