Clinical Trials Directory

Trials / Completed

CompletedNCT00536731

Symbicort Rapihaler Therapeutic Equivalence Study

A 6-week, Phase III, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy and Safety of 2 Actuations Symbicort®pMDI® 40/2.25 μg Twice Daily Compared With 1 Inhalation Symbicort Turbuhaler® 80/4.5 μg Twice Daily and 1 Inhalation Pulmicort®Turbuhaler® 100 μg Twice Daily

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
742 (actual)
Sponsor
AstraZeneca · Industry
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

Conditions

Interventions

TypeNameDescription
DRUGSymbicort TurbuhalerSymbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
DRUGSymbicort pMDISymbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
DRUGPulmicort TurbuhalerPulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Timeline

Start date
2007-09-01
Primary completion
2008-04-01
Completion
2008-04-01
First posted
2007-09-28
Last updated
2012-08-15
Results posted
2012-08-15

Locations

48 sites across 4 countries: Bulgaria, Czechia, Hungary, Poland

Source: ClinicalTrials.gov record NCT00536731. Inclusion in this directory is not an endorsement.