Last updated: 11/07/2018 18:46:58
A Randomized, Double-Blind, Active-Controlled, Parallel-Group 12-Week Trial Evaluating the Safety and Efficacy of the 50/100mcg Salmeterol/Fluticasone Propionate DISKUS Combination Product twice daily Compared with Salmeterol 50mcg via DISKUS twice daily and Fluticasone Propionate 100mcg via DISKUS twice daily in Adult and Adolescent Subjects with Asthma on Short-Acting Beta2-Agonist Therapy
Clinicaltrials.gov ID
Not applicable
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, Active-Controlled, Parallel-Group 12-Week Trial Evaluating the Safety and Efficacy of the 50/100mcg Salmeterol/Fluticasone Propionate DISKUS Combination Product twice daily Compared with Salmeterol 50mcg via DISKUS twice daily and Fluticasone Propionate 100mcg via DISKUS twice daily in Adult and Adolescent Subjects with Asthma on Short-Acting Beta2-Agonist Therapy
Trial description: A Randomized, Double-Blind, Active-Controlled, Parallel-Group 12-Week Trial Evaluating the Safety and Efficacy of the 50/100mcg Salmeterol/Fluticasone Propionate DISKUS Combination Product twice daily Compared with Salmeterol 50mcg via DISKUS twice daily and Fluticasone Propionate 100mcg via DISKUS twice daily in Adult and Adolescent Subjects with Asthma on Short-Acting Beta2-Agonist Therapy
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: Fluticasone propionate/salmeterol diskus com improves asthma-related quality of life compared components in asthma patients symptomatic on ãÿ2 agonists alone. Heather M Edin Melissa L Lang Anna K Vandermeer Karen W House Tushar P Shah. 58th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/1/2002 New York NY
Abstract: Salmeterol 50mcg/fluticasone propionate 100mcg diskus combination product demonstrates improvements in lung function regardless of baseline corticosteroid therapy. LaForce, C MD, Woodring, A MD, Baitinger, L MD, House, K MD, Prillaman, B MD, and Shah, T MD American Academy of Allergy, Asthma and Immunology 56th Annual Meeting 3/3/2000 San Diego CA
Abstract: Salmeterol/fluticasone 50/100 (sfc) dry powder inhaler (dpi) provides improved control and quality of life in patients symptomatic on inhaled corticosteroids (ics). McCarthy, T P, Edin, H M, House, K, and Vandermeer, A K 12th Annual Congress of the European Respiratory Society 9/14/2002 Stockholm Sweden
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: The salmeterol/fluticasone propionate combination (50/100mcg) via diskus has a rapid onset of effect in asthma patients on salmeterol on inhaled corticosteroids. Nathan, R MD, LaForce, C MD, Mitchell, D MD, Pearlman, D MD, Baitinger, L MD, Woodring, A MD, House, K MD, Prillaman, B MD, and Shah, T MD American Lung Association/American Thoracic Society 1999 International Conference 4/23/1999 San Diego CA
Abstract: Treatment response to fluticasone propionate/salmeterol combination product in three ethnic groups. Schoaf, L, Emmett, A, House, K, Matthews, T, and Dorinsky, P 98th International Conference of the American Thoracic Society 5/17/2002 Atlanta, GA
Edin HM, Lang ML, Vandermeer AK, House KW, Shah TP. Fluticasone propionate/salmeterol Diskus combination product improves asthma-related quality of life compared with individual components in asthma patients symptomatic on ?2 agonists alone. J Allergy Clin Immunol 2002; 109 (1): S241
Lange ML, House KW, Scott A, Shah TP, Akveld MLM. The salmeterol/fluticasone propionate combination 50/100mcg bid is effective as initial maintenance therapy in mild and moderate asthmatics. Eur Respir J 2001; 18 (Suppl 33): 263s
Rosenthal RR, Blake K, Strek M, Lange M, House KW, Vandermeer AK, et al. Fluticasone propionate/salmeterol Diskus combination product provides superior asthma control compared with fluticasone propionate and salmeterol alone in patients previously receiving PRN short-acting beta-2-agonists alone. J Allergy Clin Immunol 2002; 109 (1): S245
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
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
November 1999 to September 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
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
2000-06-09
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
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