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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00189722 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma
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Scientific title:
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Date of first enrolment:
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August 2004 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00189722 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Czech Republic
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Germany
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Poland
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Russian Federation
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Ukraine
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Contacts
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Name:
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R. G. M. vom Amsterdam, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma Europe |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma, Bronchial
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Bronchial Asthma
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Intervention(s)
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Drug: Tacrolimus
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Secondary ID(s)
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FG-506-17-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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