Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

This study has been completed.

First Received: September 12, 2005 Last Updated: April 15, 2008 History of Changes

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma Europe BV
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00189787

Purpose

This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.

Condition	Intervention	Phase
Asthma, Bronchial Bronchial Asthma	Drug: tacrolimus	Phase II

MedlinePlus related topics: Asthma

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Astellas Pharma Inc:

Enrollment:	370
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of asthma
Patients treated with inhaled corticosteroid
FEV1 (forced expiratory volume in 1 second)>60% to 80%

Exclusion Criteria:

Respiratory infection within 2 weeks
Asthma exacerbation within 90 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189787

Show 49 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Europe BV

Investigators

Study Director:

R.G.M.vom Amsterdam, MD

Astellas Pharma Europe

More Information

No publications provided

Study ID Numbers:	FG-506-17-07
Study First Received:	September 12, 2005
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00189787 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health; Hungary: National Institute of Pharmacy; Bulgaria: Bulgarian Drug Agency

Keywords provided by Astellas Pharma Inc:

Tacrolimus
Immunosuppressant
Anti-asthmatic drug
Administration, inhalation

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Immunologic Factors
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases

Hypersensitivity, Immediate
Anti-Asthmatic Agents
Asthma
Tacrolimus
Immunosuppressive Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Bronchial Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Asthma
Tacrolimus
Immunosuppressive Agents

Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009