Adults With Moderate to Severe Asthma
Study identifier:SD-004-0764
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomized, blinded, Multicenter, parallel study comparing the efficacy and safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg bid, 2.0mg bid and Pulmicort Turbuhaler at 4.00mcg bid on Adolescents (12 yrs of age and older) with adults with moderate to severe asthma.
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Budesonide
Sex
All
Actual Enrollment
900
Study type
Interventional
Age
12 Years - 150 Years
Date
Study Start Date: 01 Apr 2003
Primary Completion Date: 01 Dec 2004
Study Completion Date: 01 Dec 2004
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Pulmicort RESPULES | Drug: Budesonide 0.5mg once daily Other Name: Pulmicort RESPULES Drug: Budesonide 1mg once daily Other Name: Pulmicort RESPULES Drug: Budesonide 1mg twice daily Other Name: Pulmicort RESPULES Drug: Budesonide 2mg once daily Other Name: Pulmicort RESPULES |
| Experimental: 2 Pulmicort TURBUHALER | Drug: Budesonide 4.00mcg twice daily Other Name: Pulmicort TURBUHALER |
Contacts
Investigators
Principal Investigator
Bertil Andersson
AstraZeneca
