Last updated: 11/07/2018 18:51:12
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:
Borker R, Emmett A, Jhingran P, Rickard K, Dorinsky P. Determining economic feasibilityof fluticasone propionatesalmeterol vs montelukast in the treatment of persistent asthma using a net benefit approach and cost effectiveness acceptability curves. Annals of Allergy, Asthma, & Immunology 2005; 95: 181-189
Davis EA, Bowers B, Pepsin P, Kalberg C, Dorinsky P. The impact of fluticasone propionate/salmeterol combination product compared to oral montelukast on asthma related quality of life. Am J Respir Crit Care Med 2001; 163 (5 part 2): A506
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 PM, Kalberg C, Pepsin P, Emmett A, Rickard K. Greater onset of improvement in clinical efficacy measures with first line use of the fluticasone/salmeterol combination product compared to montelukast. Am J Respir Crit Care Med 2001; 163 (5 part 2): A865
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]
Oppenheimer JJ, Pepsin P, Kalberg C, Dorinsky P, Emmett A, Bowers B, et al. Superior asthma control with the FP/salmeterol combination product BID versus oral montelukast QD as first-line therapy. J Allergy Clin Immunol 2001; 107 (2): S98 (abstract 330)
Pearlman DS, White MV, Lieberman AK, Pepsin PJ, Kalberg C, Emmett A, Bowers B, Rickard KA, and Dorinsky P. Fluticasone propionate/salmeterol combination compared with montelukast for the treatment of persistent asthma. Ann Allergy Asthma Immunol 2002;88:227-235.
Retrospective analysis of response to therapy in subjects treated with fluticasone propionate/salmeterol 100/50mcg bid via diskus or montelukast 10mg qd. Stempel, D. A. MD, Stauffer, J. L. MD, Yancey, S. W. MS, Edwards, L. D. PhD, Hanson, K. M. BS, Sutton, L. B. PharmD, and Dorinsky, P. M. MD 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Rickard K, Dorinsky P, Yancey S, Emmett A. Comparative Efficacy of Asthma Treatments: Impact of Allergic vs. Nonallergic Status on Response to Therapy. J Allergy Clin Immunol 2003; 11 (2): S269
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
Stanford RH, Borker R, Dorinsky P, Pepsin P, Kalberg C, Emmett A, Rickard K. The costs and efficacy of fluticasone propionate/salmeterol combination versus montelukast in the treatment of adults with persistent asthma. Chest 2002; Abs No P422.
Stempel D, Sutton L, Emmett A, Dorinsky P. Variability in asthma and treatment efficacy as determined by weekly response rates with fluticasone propionate/salmeterol 100/50mcg (FSC) compared with montelukast 10mg (MON). Eur Respir J 2003; 22 (suppl 22): 259s, P1702
The fluticasone/salmeterol combination product is superior to montelukast as first-line asthma control. Dorinsky, P., Kalberg, C., Pepsin, P., Emmett, A., Bowers, B., and Rickard, K. 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)
September 1999 to August 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
2000-28-08
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
Not applicable
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