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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116103

Enrollment

Unknown

Registered

2005-06-28

Start date

2005-06-30

Completion date

2006-04-30

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Asthma, Antiasthmatics, Antiasthmatic agents

Brief summary

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

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.

Interventions

DRUGTacrolimus Inhalation Aerosol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026