Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe 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:	NCT00189722

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, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Astellas Pharma Inc:

Enrollment:	160
Study Completion Date:	July 2005
Primary Completion Date:	July 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 and long acting beta 2 agonist
FEV1(forced expiratory volume in 1 second)>50% to 80%

Exclusion Criteria:

Respiratory infection within 2weeks
Asthma exacerbation within 6 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189722

Locations

Czech Republic

Sumperk, Czech Republic, 78752

Olomouc, Czech Republic, 77520

Krhanice, Czech Republic, 25742

Brno, Czech Republic, 65691
Germany

Rudersdorf, Germany, 15562

Munchen, Germany, 80802

Wiesbaden, Germany, 65187

Deggendort, Germany, 94469

Berlin, Germany, 14050

Berlin, Germany, 10717

Hannover, Germany, 30159

Berlin, Germany, 10365

Hamburg, Germany, 20535
Poland

Krakow, Poland, 31-133

Lodz, Poland, 90-153

Tarnow, Poland, 33-100

Wroclaw, Poland, 50-434

Bialystok, Poland, 15-025

Lublin, Poland, 20-718
Russian Federation

Moscow, Russian Federation, 143420

St. Petersburg, Russian Federation, 194291

St. Petersburg, Russian Federation, 197291

St. Petersburg, Russian Federation, 197022

Smolensk, Russian Federation, 214018

Ekaterinburg, Russian Federation, 620142
Ukraine

Zaporozhye, Ukraine, 69035

Dnepropetrovsk, Ukraine, 49044

Kiev, Ukraine, 03680

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-506-17-05
Study First Received:	September 12, 2005
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00189722 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

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