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Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma

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. Identifier: NCT00189722
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Tacrolimus

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00189722

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Czech Republic
Brno, Czech Republic, 65691
Krhanice, Czech Republic, 25742
Olomouc, Czech Republic, 77520
Sumperk, Czech Republic, 78752
Berlin, Germany, 10365
Berlin, Germany, 10717
Berlin, Germany, 14050
Deggendort, Germany, 94469
Hamburg, Germany, 20535
Hannover, Germany, 30159
Munchen, Germany, 80802
Rudersdorf, Germany, 15562
Wiesbaden, Germany, 65187
Bialystok, Poland, 15-025
Krakow, Poland, 31-133
Lodz, Poland, 90-153
Lublin, Poland, 20-718
Tarnow, Poland, 33-100
Wroclaw, Poland, 50-434
Russian Federation
Ekaterinburg, Russian Federation, 620142
Moscow, Russian Federation, 143420
Smolensk, Russian Federation, 214018
St. Petersburg, Russian Federation, 194291
St. Petersburg, Russian Federation, 197022
St. Petersburg, Russian Federation, 197291
Dnepropetrovsk, Ukraine, 49044
Kiev, Ukraine, 03680
Zaporozhye, Ukraine, 69035
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
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Study Director: R. G. M. vom Amsterdam, MD Astellas Pharma Europe B.V.
Layout table for additonal information Identifier: NCT00189722    
Other Study ID Numbers: FG-506-17-05
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:
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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