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Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189787
First Posted: September 19, 2005
Last Update Posted: April 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Europe B.V.
Information provided by:
Astellas Pharma Inc
  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
Intervention Model: Parallel Assignment
Masking: Double
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189787


  Show 49 Study Locations
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

ClinicalTrials.gov Identifier: NCT00189787     History of Changes
Other Study ID Numbers: FG-506-17-07
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: April 17, 2008
Last Verified: April 2008

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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action