Last updated: 11/07/2018 18:47:58
A 12-week multicentre, randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and tolerability of fluticasone propionate/salmeterol combination (SERETIDE/VIANI/ADVAIR) 88/42mcg once daily in the morning with fluticasone propionate 88mcg once daily in the morning and placebo (short-acting ß2-agonist as required only) once daily in the morning, all via the HFA MDI as initial maintenance therapy in mild asthmatic subjects
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A 12-week multicentre, randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and tolerability of fluticasone propionate/salmeterol combination (SERETIDE/VIANI/ADVAIR) 88/42mcg once daily in the morning with fluticasone propionate 88mcg once daily in the morning and placebo (short-acting ß2-agonist as required only) once daily in the morning, all via the HFA MDI as initial maintenance therapy in mild asthmatic subjects
Trial description: A 12-week multicentre, randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and tolerability of fluticasone propionate/salmeterol combination (SERETIDE/VIANI/ADVAIR) 88/42mcg once daily in the morning with fluticasone propionate 88mcg once daily in the morning and placebo (short-acting ß2-agonist as required only) once daily in the morning, all via the HFA MDI as initial maintenance therapy in mild 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:
Abstract: Seretide/advair 50/100meg once daily is effective in patients with mild asthma. L. Goryachkinal, W. Boonsawat H. Millns S. Balsaral. 100th International Conference of the American Thoracic Society 5/21/2004 Orlando, Florida
Bailey W, Castro M, Matz J, et al. Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. Curr Med Res Opin 2008;24(6):1669–82.
Boonsawat W, Goryachkina L, Jacques L, Frith L. Combined salmeterol/fluticasone propionate versus fluticasone propionate alone in mild asthma : a placebo-controlled comparison. Clin Drug Investig 2008;28(2):101–11.
Boonsawat W, Goryachkina L, Millns H, Balsara S. The efficacy and safety of Seretide/Advair™ once daily (50/100mcg) compared with fluticasone propionate (100mcg) once daily and placebo as initial maintenance therapy in mild asthma. Am J Respir Crit Care Med 2004; 169 (7): A86
Goryachkina L, Boonsawat W, Millns H, Balsara S. Seretide/Advair™ 50/100mcg once daily is effective in patients with 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 April 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
2003-16-04
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
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