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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Europe B.V.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00189722
First received: September 12, 2005
Last updated: April 15, 2008
Last verified: April 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Czech Republic
Brno, Czech Republic, 65691
Krhanice, Czech Republic, 25742
Olomouc, Czech Republic, 77520
Sumperk, Czech Republic, 78752
Germany
Berlin, Germany, 10365
Berlin, Germany, 10717
Berlin, Germany, 14050
Deggendort, Germany, 94469
Hamburg, Germany, 20535
Hannover, Germany, 30159
Munchen, Germany, 80802
Rudersdorf, Germany, 15562
Wiesbaden, Germany, 65187
Poland
Bialystok, Poland, 15-025
Krakow, Poland, 31-133
Lodz, Poland, 90-153
Lublin, Poland, 20-718
Tarnow, Poland, 33-100
Wroclaw, Poland, 50-434
Russian Federation
Ekaterinburg, Russian Federation, 620142
Moscow, Russian Federation, 143420
Smolensk, Russian Federation, 214018
St. Petersburg, Russian Federation, 197291
St. Petersburg, Russian Federation, 194291
St. Petersburg, Russian Federation, 197022
Ukraine
Dnepropetrovsk, Ukraine, 49044
Kiev, Ukraine, 03680
Zaporozhye, Ukraine, 69035
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Investigators
Study Director: R. G. M. vom Amsterdam, MD Astellas Pharma Europe B.V.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189722     History of Changes
Other Study ID Numbers: FG-506-17-05
Study First Received: September 12, 2005
Last Updated: April 15, 2008
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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014