Last updated: 11/07/2018 18:51:23
A Randomized, Double-Blind, Double-Dummy, Parallel Group, 12-Week Comparative Trial of Salmeterol/Fluticasone Propionate Combination Product 50/100mcg Twice Daily Via the DISKUS® Inhaler Versus Oral Montelukast 10mg Once Daily in Adolescents and Adults with 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 Randomized, Double-Blind, Double-Dummy, Parallel Group, 12-Week Comparative Trial of Salmeterol/Fluticasone Propionate Combination Product 50/100mcg Twice Daily Via the DISKUS® Inhaler Versus Oral Montelukast 10mg Once Daily in Adolescents and Adults with Persistent Asthma
Trial description: A Randomized, Double-Blind, Double-Dummy, Parallel Group, 12-Week Comparative Trial of Salmeterol/Fluticasone Propionate Combination Product 50/100mcg Twice Daily Via the DISKUS® Inhaler Versus Oral Montelukast 10mg Once Daily in Adolescents and Adults with 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:
Abstract: Asthma control with fluticasone propionate/salmeterol 100/50mg diskus versus montelukast in patients previously receiving short-acting beta2 agonists. W. Calhouna L. Sutton A. Emmett P. Dorinsky. 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco CA 4
Abstract: The costs and efficacy of fluticasone propionate-salmeterol combination versus montelukast in the treatment of adults with persistent asthma. Standord, R H, Borker, R, Dorinsky, P, Pepsin, P, Kalberg, C, Emmett, A, and Rickard, K 68th Annual International Scientific Assembly and the Clinical World Congress on Diseases of the Chest 11/2/2002 San Diego CA
Abstract: The impact of fluticasone propionate/salmeterol combination product compared to oral montelukast on asthma related quality of life. Davis, E A, Bowers, B, Pepsin, B, Kalberg, C, and Dorinsky, P American Lung Association/American Thoracic Society 97th International Conference 5/18/2001 San Francisco CA
Calhoun WJ, Nelson HS, Nathan RA, Pepsin PJ, Kalberg C, Emmett A, Rickard KA, Dorinsky P. Comparison of fluticasone propionate-salmeterol combination therapy and montelukast in patients who are symptomatic on shortacting beta2-agonists alone. Am J Respir Crit. Care Med 2001;164(5):759-763.
Dorinsky P, Crim C, Yancey S, Edwards L, Rickard K. Initial maintenance therapy with fluticasone propionate/salmeterol combination product provides superior asthma control versus montelukast or fluticasone propionate alone. Eur Respir J 2002; 20 (Suppl 38): 386s
Dorinsky P, Kalberg C, Pepsin P, Emmett A, Bowers B, Rickard K. The fluticasone/salmeterol combination product is superior to montelukast as first-line asthma control. Eur Respir J 2001; 18 (Suppl 33): 263s
Dorinsky PM, Yancey SW, Edwards LD. Salmeterol response is not affected by beta;ob2;cb adrenergic receptor genotype in patients with persistent asthma. European Respiratory Journal Supplement 2005; 26: 505 (plus poster) abstr. P3301.
Dorinsky, P., Yancey, S., Edwards, L., et al. Rates of Asthma Exacerbations are Not Affected by Beta2-adrenergic Receptor Genotype in Patients with Persistent Asthma [21]. Available from http://www.posters2view.com/aaaai/ [Accessed June 2005]
Leibman CL, Pathak D, Bowers B, Dorinsky PM, Pepsin P, Kalberg C, et al. Cost-effectiveness analysis of fluticasone propionate/salmeterol combination versus montelukast in the treatment of adults with asthma. J Allergy Clin Immunol 2002; 109 (1): S185
Nelson, H., Yancey, S., Emmett, A., et al. Incidence of Asthma Exacerbations by Season and the Effects of Treatment with Fluticasone propionate/Salmeterol (FSC) or Fluticasone propionate (FP) Compared with Montelukast [6]. Available from http://www.posters2view.com/aaaai/ Accessed June 2005
Rickard K, Dorinsky PM, Knobil K, Pepsin, P, Akveld MLM. The salmeterol/fluticasone propionate combination 50/100mcg bid is more effective than oral montelukast 10 mg od as first line therapy in mild and moderate asthmatics. Eur Respir J 2001; 18 (Suppl 33): 262s
Schoaf L, Emmett A, House K, Matthews T, Dorinsky P. Treatment response to fluticasone propionate/salmeterol combination product in three ethnic groups. Am J Respir Crit Care Med 2002; 165 (8): A568
Sheth K, Borker R, Emmett A, Rickard K, Dorinsky P. Cost-effectiveness comparison of salmeterol/fluticasone propionate versus montelukast in the treatment of adults with persistent asthma. Pharmacoeconomics 2002; 20 (13): 909-918
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
September 1999 to September 2000
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
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
2000-21-09
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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