Safety and efficacy study of Budesonide (Pulmicort®) Turbuhaler® in Japanese children with bronchial asthma
Study identifier:D5254C00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An open-label, multi-center, long term study to investigate the safety and efficacy of budesonide Turbuhaler® treatment for 48 weeks (following 6 weeks Phase III study) in Japanese children with bronchial asthma aged 5 years to 15 years old
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Budesonide, Conventional Asthma Therapy
Sex
All
Actual Enrollment
241
Study type
Interventional
Age
5 Years - 15 Years
Date
Study Start Date: 01 Dec 2006
Primary Completion Date: 01 Oct 2008
Study Completion Date: 01 Oct 2008
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: BUD - Budesonide Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily | Drug: Budesonide Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily Other Name: Pulmicort® Turbuhaler® |
| Active Comparator: CONV - Conventional Asthma Therapy Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. | Drug: Conventional Asthma Therapy According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
Contacts
Investigators
Principal Investigator
Lars-Goran Carlsson
AstraZeneca R&D Lund
