Last updated: 11/07/2018 18:40:11
A 12-week multicentre, randomised, double-blind, double-dummy, parallel group study to compare the efficacy and tolerability of once daily salmeterol/fluticasone propionate combination (salm/FP) 50/100mcg at night via the DISKUS/ACCUHALER with once daily budesonide (BUD) 400mcg at night via a breath-actuated dry powder inhaler (BADPI) as initial maintenance therapy in mild-to-moderate asthmatic subjects
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-week multicentre, randomised, double-blind, double-dummy, parallel group study to compare the efficacy and tolerability of once daily salmeterol/fluticasone propionate combination (salm/FP) 50/100mcg at night via the DISKUS/ACCUHALER with once daily budesonide (BUD) 400mcg at night via a breath-actuated dry powder inhaler (BADPI) as initial maintenance therapy in mild-to-moderate asthmatic subjects
Trial description: A 12-week multicentre, randomised, double-blind, double-dummy, parallel group study to compare the efficacy and tolerability of once daily salmeterol/fluticasone propionate combination (salm/FP) 50/100mcg at night via the DISKUS/ACCUHALER with once daily budesonide (BUD) 400mcg at night via a breath-actuated dry powder inhaler (BADPI) as initial maintenance therapy in mild-to-moderate asthmatic subjects
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Vogelmeier, C., D'Urzo, A., Pauwels, R., Merino, J. M., Jaspal, M., Boutet, S., Naya, I., and Price, D. Eur Respir J 2005; 26. 26(5. 5):819-28, 819-28.
Pauwels R, Smiltena I, Bagdonas A, Eliraz E, Firth R. Seretide 50/100 once daily is more effective than budesonide 400mcg once daily in mild asthma. Am J Respir Crit Care Med 2004; 169 (7): A86
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
April 2002 to March 2003
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-27-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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