Study to evaluate efficacy and safety of Pulmicort Respules in Japanese adult asthmatic patients
Study identifier:D5259C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An evaluation of efficacy and safety of corresponding doses of Pulmicort Turbuhaler® and Pulmicort Respules® in Japanese asthmatic adult patients (open, multicenter, phase III study)
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Budesonide, Pulmicort Turbuhaler
Sex
All
Actual Enrollment
108
Study type
Interventional
Age
16 Years +
Date
Study Start Date: 01 Feb 2009
Primary Completion Date: 01 Aug 2009
Study Completion Date: 01 Aug 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2011 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Four weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily | Drug: Budesonide Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks Other Name: Pulmicort |
| Experimental: 2 Pulmicort Turbuhaler at a dose of 200 μg twice daily and Pulmicort Respules at a dose of 0.5 mg twice daily or 1.0 mg once daily (low dose) | Drug: Pulmicort Turbuhaler Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler |
Contacts
Investigators
Principal Investigator
Lars-Göran Carlsson
AstraZeneca R&D Lund
