New version Pulmicort Turbuhaler USA Children
Study identifier:SD-004-0726
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Placebo-controlled comparison of the efficacy, safety and pharmacokinetics of the current US version of Pulmicort (Budesonide) Turbuhaler and the new version of Pulmicort Turbuhaler in Asthmatic children and Adolescents.
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
budesonide
Sex
All
Actual Enrollment
430
Study type
Interventional
Age
6 Years - 17 Years
Date
Study Start Date: 01 Nov 2002
Primary Completion Date: 01 Sept 2004
Study Completion Date: 01 Sept 2004
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double 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
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Contacts
Investigators
Principal Investigator
Bertil Andersson
AstraZeneca employee
