Last updated: 11/07/2018 18:49:16
A 12-week, randomised, double-blind, parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination 50/100 mcg bd with fluticasone propionate 250 mcg bd, all via the DISKUS/ACCUHALER on maintaining asthma control in moderate persistent asthmatic subjects whose symptoms have been well-controlled following an initial maintenance therapy with salmeterol/fluticasone propionate 50/250 mcg combination twice-daily for 12 weeks.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-week, randomised, double-blind, parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination 50/100 mcg bd with fluticasone propionate 250 mcg bd, all via the DISKUS/ACCUHALER on maintaining asthma control in moderate persistent asthmatic subjects whose symptoms have been well-controlled following an initial maintenance therapy with salmeterol/fluticasone propionate 50/250 mcg combination twice-daily for 12 weeks.
Trial description: A 12-week, randomised, double-blind, parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination 50/100 mcg bd with fluticasone propionate 250 mcg bd, all via the DISKUS/ACCUHALER on maintaining asthma control in moderate persistent asthmatic subjects whose symptoms have been well-controlled following an initial maintenance therapy with salmeterol/fluticasone propionate 50/250 mcg combination twice-daily for 12 weeks.
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:
Bateman E Atienza T Mihaescu T Duggan M Jacques L Goldfrad C . Asthma control is maintained if treatment with fluticasone propionate/salmeterol (FSC; Advair/Seretide) is stepped down. Proc. Am. Thorac. Soc. 2005;2(-):A570 Abs No C12.
Bateman E, Atienza T, Mihaescu T, et al. Asthma control is maintained if treatment with fluticasone propionate/ salmeterol (FSC; adavair(Rm)/seretide(Rm)) is stepped down. Proceedings of the American Thoracic Society 2005; 2: 570.
Bateman ED, Jacques L, Goldfrad C. Asthma control can be maintained when fluticasone propionate/salmeterol in a single inhaler is stepped down. Journal of Allergy and Clinical Immunology 2006; 117: 563-570.
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
February 2003 to December 2003
Type
Not applicable
Phase
2/3
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
2003-15-12
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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