- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00189722
Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma
April 15, 2008 updated by: Astellas Pharma Inc
This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brno, Czech Republic, 65691
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Krhanice, Czech Republic, 25742
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Olomouc, Czech Republic, 77520
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Sumperk, Czech Republic, 78752
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Berlin, Germany, 10717
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Berlin, Germany, 14050
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Berlin, Germany, 10365
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Deggendort, Germany, 94469
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Hamburg, Germany, 20535
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Hannover, Germany, 30159
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Munchen, Germany, 80802
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Rudersdorf, Germany, 15562
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Wiesbaden, Germany, 65187
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Bialystok, Poland, 15-025
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Krakow, Poland, 31-133
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Lodz, Poland, 90-153
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Lublin, Poland, 20-718
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Tarnow, Poland, 33-100
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Wroclaw, Poland, 50-434
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Ekaterinburg, Russian Federation, 620142
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Moscow, Russian Federation, 143420
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Smolensk, Russian Federation, 214018
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St. Petersburg, Russian Federation, 197022
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St. Petersburg, Russian Federation, 194291
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St. Petersburg, Russian Federation, 197291
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Dnepropetrovsk, Ukraine, 49044
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Kiev, Ukraine, 03680
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Zaporozhye, Ukraine, 69035
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of asthma
- Patients treated with inhaled corticosteroid and long acting beta 2 agonist
- FEV1(forced expiratory volume in 1 second)>50% to 80%
Exclusion Criteria:
- Respiratory infection within 2weeks
- Asthma exacerbation within 6 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: R. G. M. vom Amsterdam, MD, Astellas Pharma Europe B.V.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
April 17, 2008
Last Update Submitted That Met QC Criteria
April 15, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Calcineurin Inhibitors
- Tacrolimus
Other Study ID Numbers
- FG-506-17-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Taro Pharmaceuticals USACompleted
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Peking Union Medical College HospitalUnknown
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Technical University of MunichCompleted
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