A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Scottsdale, Arizona, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tacrolimus Inhalation Aerosol

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

Astellas Pharma US, Inc.

Registry information

Official study 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

Important dates

Study start: 2005
Study completion: 2006
First posted: Jun 28, 2005
Registry last updated: Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed