Comparing Symbicort® as-Needed or Bricanyl as-Needed or Pulmicort® once daily + Bricanyl as-Needed in asthma patients - MIA
Study identifier:D5890L00032
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomised, double blind, placebo controlled, parallel-group study with use of budesonide/formoterol "as-needed", or terbutaline "as-needed" or regular use of budesonide + terbutaline "as-needed", in patients with mild intermittent asthma
Medical condition
Exercise induced asthma
Phase
Phase 2
Healthy volunteers
No
Study drug
budesonide, terbutaline, budesonide/formoterol
Sex
All
Actual Enrollment
66
Study type
Interventional
Age
12 Years +
Date
Study Start Date: 01 Sept 2009
Primary Completion Date: 01 Jul 2010
Study Completion Date: 01 Jul 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
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 |
|---|---|
| Active Comparator: A budesonide 400yg + terbutaline 0.4 mg as-needed | Drug: budesonide 400 yg x 1 Other Name: Pulmicort Turbuhaler Drug: terbutaline 0.4 mg as-needed Other Name: Bricanyl Turbuhaler |
| Active Comparator: B placebo + terbutaline 0.4 mg as-needed | Drug: terbutaline 0.4 mg as-needed Other Name: Bricanyl Turbuhaler |
| Active Comparator: C placebo + budesonide/formoterol 160/4.5 yg as-needed | Drug: budesonide/formoterol 160/4.5 yg as-needed Other Name: Symbicort Turbuhaler |
Contacts
Investigators
Principal Investigator
Kjell Larsson
AstraZeneca MC Sweden
