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

Astellas

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Tacrolimus Inhalation Aerosol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00116103

04-0-213

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind