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

NCT ID: NCT00116103

Last Updated: 2012-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tacrolimus Inhalation Aerosol

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Astellas Medical Monitor, MD

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Scottsdale, Arizona, United States

Site Status

Encinitas, California, United States

Site Status

Los Angeles, California, United States

Site Status

San Diego, California, United States

Site Status

San Jose, California, United States

Site Status

Denver, Colorado, United States

Site Status

Daytona Beach, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Boise, Idaho, United States

Site Status

River Forest, Illinois, United States

Site Status

South Bend, Indiana, United States

Site Status

St Louis, Missouri, United States

Site Status

Missoula, Montana, United States

Site Status

Omaha, Nebraska, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Providence, Rhode Island, United States

Site Status

Spartanburg, South Carolina, United States

Site Status

San Antonio, Texas, United States

Site Status

Madison, Wisconsin, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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04-0-213

Identifier Type: -

Identifier Source: org_study_id

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