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Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

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ClinicalTrials.gov Identifier: NCT00189787
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : April 17, 2008
Astellas Pharma Europe B.V.
Information provided by:
Astellas Pharma Inc

Brief Summary:
This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.

Condition or disease Intervention/treatment Phase
Asthma, Bronchial Bronchial Asthma Drug: tacrolimus Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

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

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

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

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.
Study Director: R.G.M.vom Amsterdam, MD Astellas Pharma Europe B.V.

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

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action