Last updated: 11/07/2018 18:46:01
A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol/Fluticasone Propionate Combination in HFA 134a MDI, 42/88mcg BID, and Salmeterol in Propellant 11/12 MDI, 42mcg BID, Fluticasone Propionate in Propellant ...
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 Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol/Fluticasone Propionate Combination in HFA 134a MDI, 42/88mcg BID, and Salmeterol in Propellant 11/12 MDI, 42mcg BID, Fluticasone Propionate in Propellant ...
Trial description: A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol/Fluticasone Propionate Combination in HFA 134a MDI, 42/88mcg BID, and Salmeterol in Propellant 11/12 MDI, 42mcg BID, Fluticasone Propionate in Propellant ...
Primary purpose:
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Trial design:
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Masking:
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Allocation:
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Primary outcomes:
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Secondary outcomes:
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Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Combination salmeterol fluticasone propionate administered by diskus improves quality of life in ptients with chronic obstructive pulmonary disease. Edin, H M, Price, M J, Davis, S L, Ho, S, Jenkins, R J, Lee, B T, Wire, P D, and Horstman, D H American College of Chest Physicians 67th Annual International Scientific Assembly and the Clinical World Congress on Diseases of the Chest 11/4/2001 Philadelphia PA
Abstract: Efficacy of the salmeterol/fluticasone propionate dry powder combination product in the diskus: a stratified study in patients on salmeterol alone or inhaled corticosteroids. Wolfe, J MD, Bell, T MD, Raphael, G MD, Weinstein, S MD, Baitinger, L MD, Woodring, A MD, Prillaman, B MD, House, K MD, and Shah, T MD 55th Annual Meeting of the American Academy of Allergy, Asthma and Immunology and 11th Annual Allied Health Meeting 2/26/1999 Orlando FL
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 Immunology New York NY
Abstract: Fluticasone propionate/salmeterol hfa mdi has a rapid onset of effect in asthmatics treated with short or long-acting 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 Francisco CA
Abstract: Fluticasone propionate/salmeterol hfa midi combination product demonstrates superior improvements in lung function regardless of baseline asthma severity. Baitinger, L, Dorinsky, P, House, K, Matthews, P, Scott, C, and VanderMeer, A. 98th International Conference of the American Thoracic Society 5/17/2002 Atlanta GA
Abstract: Low dose salmeterol/fluticasone propionate combination (sfc) via metered dose inhaler (mdi) improves asthma control and quality of life in patients not well controlled on inhaled steroids (ics). McCarthy, T P, Edin, H M, House, K, Vandermeer, A K, and Scott, C 12th Annual Congress of the European Respiratory Society 9/14/2002 Stockholm Sweden
Abstract: Quality of life and asthma control assessment in patients previously on inhaled corticosteroids (ics), treated with salmeterol/fluticasone combination (sfc) metered dose inhaler (mdi). McCarthy, T P, Edin, H M, House, K, and Vandermeer, A K Winter Meeting of the British Thoracic Society 12/5/2001 London UK
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 50mcg/fluticasone propionate 250mcg diskus combination product demonstrates improvements in lung function regardless of baseline corticosteroid therapy. Pearlman, D MD, Baitinger, L MD, Woodring, A MD, Prillaman, B MD, House, K MD, and Shah, T MD American Lung Association/American Thoracic Society 96th International Conference 5/5/2000
Abstract: Salmeterol response is not affected by beta2- adrenergic receptor genotype in patients with persistent asthma. Dorinsky, Paul M. MD, Yancey, Steve MS, Baitinger, Leslie BS, Edwards, Lisa PhD, Sutton, Laura PharmD, Klotsman, Michael PhD, and Anderson, Wayne PhD 70th Annual Meeting of the American College of Chest Physicians 10/23/2004 Seattle, WA; USA
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 combination improves health status in copd patients. Jones, P W, Edin, H W, and Anderson, J 98th International Conference of the American Thoracic Society 5/17/2002 Atlanta GA
Abstract: The effects of salmeterol/fluticasone combination (sfc) dry powder inhaler (dpi) on asthma control and quality of life, in patients previously treated with inhaled corticosteroids (ics). McCarthy, T P, Edin, H M, House, K, Yan, S K, and Vandermeer, A K Winter Meeting of the British Thoracic Society 12/5/2001 London UK
Abstract: The salmeterol xinafoate/fluticasone propionate dry powder combination product via diskus inhaler improves asthma control compared to salmeterol xinafoate or fluticasone propionate dry powder alone. Mitchell, D MD, Gross, G MD, Woodring, A MD, Shah, T MD, Chervinsky, P MD, Edwards, T MD, Baitinger, L MD, Prillaman, B MD, and House, K MD American Lung Association/American Thoracic Society 1998 International Conference 4/24/1998 Chicago IL
Abstract: The salmeterol xinafoate/fluticasone propionate dry powder combination product via diskus inhaler improves asthma control compared to the individual products in patients previously treated with inhaled corticosteroids. White, M MD, Shapiro, G MD, Taylor, J MD, Dunn, K MD, Woodring, A MD, Baitinger, L MD, Prillaman, B MD, House, K MD, and Shah, T MD American Lung Association/American Thoracic Society 1999 International Conference 4/23/1999 San Diego CA
Abstract: The salmeterol/fluticasone propionate (50/250mcg) dry powder combination diskus has a faster onset of effect compared with salmeterol or fluticasone propionate in patients with asthma. Lumry, W MD, Mendelson, L MD, Pedinoff, A MD, Prillaman, B MD, Baitinger, L MD, Woodring, A MD, House, K MD, and Shah, T MD 55th Annual Meeting of the American Academy of Allergy, Asthma and Immunology and 11th Annual Allied Health Meeting 2/26/1999 Orlando FL
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: The salmeterol/fluticasone propionate combination product improves asthma control compared with the individual products in asthmatics treated with prn short-acting beta2-agonists alone. Nelson, H MD, Chervinsky, P MD, Greos, L MD, Pleskow, W MD, Baitinger, L MD, Scott, C MD, House, K MD, Payne, E MD, and Shah, T MD American Lung Association/American Thoracic Society 96th International Conference 5/5/2000 Toronto ON Canada
Abstract: The salmeterol/fluticasone propionate diskus combination decreases the incidence of exacerbations compared to treatment with salmeterol or fluticasone propionate alone. Nathan, R, Woodring, A, Baitinger, L, Prillaman, B, Faris, M, House, K, and Shah, T 1999 Annual Congress of the European Respiratory Society 10/9/1999 Madrid Spain
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
Baitinger L, Dorinsky P, House K, Matthews P, Scott, C, VanderMeer A. Fluticasone propionate/salmeterol HFA MDI combination product demonstrates superior improvements in lung function regardless of baseline asthma severity. Am J Respir Crit Care Med 2002; 165 (8): A568
Edin HM, Payne E, Herrle MR, Schoaf L, Mather DB, Scott CA, et al. Salmeterol/fluticasone propionate combination via HFA MDI improves quality of life in asthma patients. J Allergy Clin Immunol 2001; 107 (2): S246: A806
Efficacy and safety of fluticasone propionate 44 microg/salmeterol 21 microg administered in a hydrofluoroalkane metered-dose inhaler as an initial asthma maintenance treatment. Nelson, H. S., Wolfe, J. D., Gross, G., Greos, L. S., Baitinger, L., Scott, C., and Dorinsky, P. Ann Allergy Asthma Immunol 2003; 91(3):263-9
Fluticasone propionate and salmeterol administered via diskus compared with salmeterol or fluticasone propionate alone in patients suboptimally controlled with short-acting beta2-agonists. Murray, J., Rosenthal, R., Somerville, L., Blake, K., House, K., Baitinger, L., VanderMeer, A., and Dorinsky, P. Ann Allergy Asthma Immunol 2004; 93(4):351-9
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
McCarthy TP, Edin H, House, K, Vandermeer AK. Quality of life and asthma control assessment in patients previously treated with inhaled corticosteroids (ICS), treated with salmeterol/fluticasone combination (SFC) metered dose inhaler (MDI). Thorax 2001; 56 (Suppl III): 64
McCarthy TP, Edin HM, House K, Vandermeer AK, Scott C. Low dose salmeterol/fluticasone propionate combination (SFC) via metered dose inhaler (MDI) improves asthma control and quality of life in patients not well controlled on inhaled steroids (ICS). Eur Respir J 2002; 20 (Suppl 38): 47s
Nathan RA, Mitchell D, Condemi J, Heller A, Schoaf L, Herrle M, et al. Cardiovascular and hypothalamic-pituitary-adrenal 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
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
Weinstein SF, Pearlman DS, Condemi JJ, Herrle MR, Scott CA, Payne JE, House KW, Shah TP. Superior efficacy of the fluticasone propionate/salmeterol (88/42mcg) HFA-MDI combinationproduct versus the individual components in asthmatics previously treated with either short- or long-acting beta-2-agonists or inhaled corticosteroids. J Allergy Clin Immunol 2001; 107 (2): S102 (abstract 339)
White M, Scott C, Herrle MR, Pearlman D, Payne E, House K, et al. Salmeterol/fluticasone propionate (42/88mcg) HFA-MDI improves asthma control in asthmatics previously treated with short- or long-acting beta-2-agonists or inhaled corticosteroids. Ann Allergy Asthma Immunol 2001; 86 (1): 81
combined salmeterol 50 microg and fluticasone propionate 250 microg in the diskus device for the treatment of asthma. Shapiro, G., Lumry, W., Wolfe, J., Given, J., White, M. V., Woodring, A., Baitinger, L., House, K., Prillaman, B., and Shah, T. Am J Respir Crit Care Med 2000; 161(2 Pt 1):527-34
mproved ability to perform strenuous activities after treatment with fluticasone propionate/salmeterol combination in patients with persistent asthma. Nathan, R. A., Dorinsky, P., Rosenzweig, J. R., Shah, T., Edin, H., and Prillaman, B. J Asthma 2003; 40(7):815-22
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
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Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1999-05-11
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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