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NCT00189787 Clinical Trial

Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

Bronchial Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189787
Other study ID # FG-506-17-07
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated April 15, 2008
Est. completion date August 2005

Study information
Verified date April 2008
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlPoland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthHungary: National Institute of PharmacyBulgaria: Bulgarian Drug Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 370
Est. completion date August 2005
Est. primary completion date August 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tacrolimus

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Germany,  Hungary,  Poland,  Russian Federation,  Ukraine, 

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