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Note: This record shows only 22 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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00189787
Date of registration: 12/09/2005
Prospective Registration: No
Primary sponsor: Astellas Pharma Inc
Public title: Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma
Scientific title:
Date of first enrolment: August 2004
Target sample size: 370
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00189787
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Bulgaria Czech Republic Germany Hungary Poland Russian Federation Ukraine
Contacts
Name:     R.G.M.vom Amsterdam, MD
Address: 
Telephone:
Email:
Affiliation:  Astellas Pharma Europe B.V.
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Asthma, Bronchial
Bronchial Asthma
Intervention(s)
Drug: tacrolimus
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
FG-506-17-07
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Astellas Pharma Europe B.V.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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