Last updated: 11/07/2018 18:46:14
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol/Fluticasone Propionate Combination...
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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol/Fluticasone Propionate Combination...
Trial description: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol/Fluticasone Propionate Combination...
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: A side-by-side comparison of the efficacy and safety of fluticasone propionate/salmeterol diskus with fluticasone propionate diskus and hfa in 4-11 year-olds with asthma. Scott, C., Schoaf, L., Wu, W. PhD, Ellsworth, A., and Crim, C. MD RTP NC 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Abstract: Cardiovascular and hypathalamic-pituitary-adrenal axis safety of fluticasone propionate/salmeterol hfa mdi in adolescent and adult patients with asthma. Nathan, R A, Mitchell, D, codemi, J, Heiller, A, Schoar, L, herrle, M, Scott, C, House, K, Payne, E, and Shah, T American Lung Association/American Thoracic Society 97th International Conference 5/18/2001 San Fransisco, Ca
Abstract: Fluticasone propionate/salmeterol hfa mdi has a rapid onset of effect in asthmatics treated with short or longacting beta2-agonists or inhaled corticosteroids. Perlman, D S, Kent, E, Lanz, M J, Peden, D, Baitinger, L, Herrle, M, Schoaf, L, Scott, C, Payne, E, and Shah, T American Lung Association/American Thoracic Society 97th International Conference 5/18/2001 San Fransisco, Ca
Abstract: Salmeterol/fluticasone propionate (500/100 micrograms dose) non-cfc metered dose inhaler is safe and effective in patients with asthma using short-acting beta2-agonists alone. Nelson, H S, Baitinger, L, Scott, C, House, K, Payne, E, and Shah, T World Congress on Lung Health and 10th European Respiratory Society Annual Congress 8/30/2000 Florence Italy
Abstract: Superior efficacy of the fluticasone propionate/salmeterol (88/42mcg) hfa-mdi combination product versus the, individual components in asthmatics previously treated with either short-or long-acting beta2-agonists or inhaled corticosteroids. Weinstein, S F, Pearlman, D S, Condemi, JJ, Herrle, M R, Scott, C A, Payne, J E, House, K W, and Chicago IL
Abstract: The fluticasone propionate/salmeterol hfa mdi is significantly more efficacious on treating asthma than placebo hfa, mdi, fluticasone propionate cfc mdi or salmeterol cfc mdi. Rooklin, A, Elkayama, D, Weilerm, J, Windom, H, Schoaf, L, Scott, C, House, K W, Payne, J E, and Shah, T. American Academy of Allergy, Asthma and Immunology 57th Annual Meeting 3/16/2001 New Orleans LA
Edin HM, Payne E, Herrle MR, Schoaf L, Mather DB, Scott CA, Shah TP. Salmeterol/fluticasone propionate combination via HFA MDI improves quality of life in asthma patients. J Allergy Clin Immunol 2001;107(2):S246.
Nathan RA, Mitchell D, Condemi J, Heller A, Schoaf L, Herrle M, Scott C, House K, Payne E, Shah T. Cardiovascular and hypothalamic-pituitary-adrenal axis safety of fluticasone propionate/salmeterol HFA MDI in adolescent and adult patients with asthma. AM. THORAC. SOC. ANNU. MEET. 2001;(ABSTRACTS CD):D31-K45.
Nathan RA, Mitchell D, Condemi J, Heller A, Schoaf L, Herrle M, et al. Cardiovascular and hypothalamic-pituitaryadrenal axis safety of fluticasone propionate/salmeterol HFA MDI in adolescent and adult patients with asthma. Am J Respir Crit Care Med 2001; 163 (5 part 2): A863
Nathan RA, Rooklin A, Schoaf L. Efficacy and tolerability of fluticasone propionate/salmeterol administered twice daily via hydrofluoroalkane 134a metered-dose inhaler in adolescent and adult patients with persistent asthma: a randomized, double-blind, placebo- controlled, 12 week study. Clinical Therapeutics 2006; 28: 73-85.
Pearlman DS, Kent E, Lanz MJ, Peden D, Baitinger L, Herrle M, et al. Fluticasone propionate/salmeterol HFA MDI has a rapid onset of effect in asthmatics treated with short or long-acting beta2-agonists (BA) or inhaled corticosteroids (ICS). Am J Respir Crit Care Med 2001; 163 (5 part 2): A865
Pearlman DS, Kent E, Lanz MJ,Peden D, Baitinger L, Herrle M, Schoaf L, Scott C, Payne E, Shah T. Fluticasone propionate/salmeterol HFA MDI has a rapid onset of effect in asthmatics treated with short or long-acting beta2- agonists (BA) or inhaled corticosteroids (ICS). AM. THORAC. SOC. ANNU. MEET. 2001;(ABSTRACTS CD):D31-K57.
Rooklin A, Elkayam D, Weiler J, Windom H, Schoaf L, Scott C, House KW, Payne JE, Shah T. The fluticasone propionate salmeterol HFA MDI is significantly more efficacious in treating asthma than placebo HFA mdi, fluticasone propionate CFC MDI or salmeterol CFC MDI. J Allergy Clin Immunol 2001;107(2):S100.
Rooklin A, Elkayam D, Weiler J, Windom H, Schoaf L, Scott C, et al. The fluticasone propionate/salmeterol HFA MDI is significantly more efficacious in treating asthma than placebo HFA MDI, fluticasone propionate CFC MDI or salmeterol CFC MDI. J Allergy Clin Immunol 2001; 107 (2): S100 (abstract 335)
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
December 1998 to March 2000
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
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
2000-14-03
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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