Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

This study has been completed.
Astellas Pharma Europe B.V.
Information provided by:
Astellas Pharma Inc Identifier:
First received: September 12, 2005
Last updated: April 15, 2008
Last verified: April 2008
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: 370
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

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

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
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 identifier: NCT00189787

  Show 49 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Study Director: R.G.M.vom Amsterdam, MD Astellas Pharma Europe B.V.
  More Information

No publications provided Identifier: NCT00189787     History of Changes
Other Study ID Numbers: FG-506-17-07 
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
Hungary: National Institute of Pharmacy
Bulgaria: Bulgarian Drug Agency

Keywords provided by Astellas Pharma Inc:
Anti-asthmatic drug
Administration, inhalation

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 04, 2016