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

Astellas Pharma Inc

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Asthma

Interventions

Tacrolimus Inhalation AerosolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (21)

Unnamed facility

Scottsdale, Arizona, United States

Unnamed facility

Encinitas, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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