Study 17 of 1098 for search of: "Asthma"
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Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma
This study has been completed.
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 Tacrolimus anhydrous
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

Study ID Numbers: FG-506-17-07
Study First Received: September 12, 2005
Last Updated: April 15, 2008
ClinicalTrials.gov Identifier: NCT00189787  
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
Respiratory Tract Diseases
Lung Diseases
 Hypersensitivity, Immediate
Asthma
Tacrolimus
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immunologic Factors
Immune System Diseases
Bronchial Diseases
 Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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