At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 51 enrolled
Drug / intervention
GW815SF HFA MDI +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate DPI Plus Fluticasone Propionate DPI and to Assess Long-term Safety of GW815SF HFA MDI
In Brief
A Phase 3 clinical trial evaluating GW815SF HFA MDI and salmeterol and fluticasone propionate for Bronchial Asthma. Completed, enrolled 51 participants across 8 sites.
Detailed Summary
To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma. To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchial Asthma
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2007
Enrollment StartApr 2007
Primary CompletionJan 2008
TodayJul 2026
First PostedMar 16, 2007
Enrollment StartApr 1, 2007
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.3 years ago
Interventions
GW815SF HFA MDIdrug
salmeterol and fluticasone propionate combination
salmeterol and fluticasone propionatedrug
salmeterol + fluticasone propionate