Last updated: 11/07/2018 18:49:00
A 12-week, multi-centre, randomised, double-blind, parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination (SERETIDE™/VIANI™/ADVAIR™) 50/250μg twice-daily with fluticasone propionate 250μg twice-daily, all via the DISKUS®/ACCUHALER® as initial maintenance therapy in moderate persistent asthma.
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, multi-centre, randomised, double-blind, parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination (SERETIDE™/VIANI™/ADVAIR™) 50/250μg twice-daily with fluticasone propionate 250μg twice-daily, all via the DISKUS®/ACCUHALER® as initial maintenance therapy in moderate persistent asthma.
Trial description: A 12-week, multi-centre, randomised, double-blind, parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination (SERETIDE™/VIANI™/ADVAIR™) 50/250μg twice-daily with fluticasone propionate 250μg twice-daily, all via the DISKUS®/ACCUHALER® as initial maintenance therapy in moderate persistent asthma.
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:
Barnes, N., Rojas, R., Paluga, I., et al. Efficacy and Safety of Fluticasone Propionate/Salmeterol (250/50g bd) in a Single Diskus Device Compared with Fluticasone Propionate Diskus Alone (250g bd) as Initial Maintenance Therapy in Moderate Asthma [B35] [Poster: G13]. Available from http://www.abstracts2view.com/ats05/ [Accessed June 2005]
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
February 2003 to September 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
2003-26-09
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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