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Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Europe BV
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00189787
First received: September 12, 2005
Last updated: April 15, 2008
Last verified: April 2008
History of Changes
  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:

MedlinePlus related topics: Asthma
Drug Information available for: Tacrolimus
U.S. FDA Resources

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

ClinicalTrials.gov 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:
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
Anti-Asthmatic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013