Last updated: 11/07/2018 18:39:46
A phase IV, multicentre, randomised, double blind, single dummy, parallel group study to compare the anti-inflammatory action of Seretide 50/100 bd via MDI with Flixotide 100mg bd via MDI plus montelukast 10mg od for 12 weeks in adults with mild to moderate asthma who are currently taking…
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 phase IV, multicentre, randomised, double blind, single dummy, parallel group study to compare the anti-inflammatory action of Seretide 50/100 bd via MDI with Flixotide 100mg bd via MDI plus montelukast 10mg od for 12 weeks in adults with mild to moderate asthma who are currently taking…
Trial description: A phase IV, multicentre, randomised, double blind, single dummy, parallel group study to compare the anti-inflammatory action of Seretide 50/100 bd via MDI with Flixotide 100mg bd via MDI plus montelukast 10mg od for 12 weeks in adults with mild to moderate asthma who are currently taking…
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:
A comparison of the anti-inflammatory and clinical effects of salmeterol 25mcg/ fluticasone propionate 50mcg combination (SFC 50) with fluticasone propionate (FP) plus montelukast (M) in patients with mild to moderate asthma. McCarthy TP, Woodcock AA, Pavord ID, Allen DJ, Parker D, Rice L. Poster at ATS 2003; Am J Resp & Crit Care Med 2003; 167; supp 7: A367
Abstract: Asthma control with fluticasone propionate/salmeterol 100/50mcg diskus® versus montelukast in patients previously receiving short-acting beta-agonists. Calhoun, W. 1, Sutton, L. 2, Emmett, A. 2, and Dorinsky, P. 2 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco, CA; USA
Abstract: Effects of triple therapy with fluticasone/salmeterol combination and montelukast on surrogate inflammatory outcomes. G.P. Currie, D. K. Lee K. Haggart C. E. Bates B. J. Lipworth. 99th International Conference of the American Thoracic Society 5/16/2003 Seattle WA
Abstract: Salmeterol/fluticasone propionate combination 50/100 mg bid is more effective than fluticasone propionate 100 mg bid plus montelukast 10 mg once daily in reducing exacerbations. Gold, M., Jõgi, R., Mulder, P. G. H., and Akveld, M. L. M. 11th Annual Congress of the European Respiratory Society 9/22/2001 Berlin; Germany
Abstract: The salmeterol/fluticasone propionate combination 50/100 mg bid is more effective than oral montelukast 10 mg od as a first line therapy in mild and moderate asthmatics. Rickard, K., Dorinsky, P. M., Knobil, K., Pepsin, P., and Akveld, M. L. M. 11th Annual Congress of the European Respiratory Society 9/22/2001 Berlin; Germany
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
May 2001 to August 2002
Type
Not applicable
Phase
4
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
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
2002-30-08
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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