Last updated: 11/07/2018 18:45:50
A Randomized, Double-Blind, Active-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, and Fluticasone Propionate in Propellant 11/12 MD ...
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, Active-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, and Fluticasone Propionate in Propellant 11/12 MD ...
Trial description: A Randomized, Double-Blind, Active-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, and Fluticasone Propionate in Propellant 11/12 MD ...
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: 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 USA
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: 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 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
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 (44/21) 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, J J, Herrie, M R, Scott, C A, Payne, J E, House, K W, and Shah, T P. 3rd Triennial World Asthma Meeting 7/13/2001 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 USA
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: 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 Fransisco, 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 Toronto ON Canada
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
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
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
Efficacy and safety of fluticasone propionate/salmeterol hfa 134a mdi in patients with mild-to-moderate persistent asthma. Pearlman, D. S., Peden, D., Condemi, J. J., Weinstein, S., White, M., Baitinger, L., Scott, C., Ho, S. Y., House, K., and Dorinsky, P. J Asthma 2004; 41(8):797-806
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
Nelson HS, Baitinger L, Scott C, House K, Payne E, Shah T. Salmeterol/fluticasone propionate (50/100mug dose) non-CFC metered dose inhaler is safe and effective in patients with asthma using short-acting beta2-agonists alone. Eur Respir J 2000;16(4): 508
Nelson HS, Chervinsky P, Greos L, Pleskow W, Baitinger L, Scott C, House C, Payne E, Shah T. The salmeterol/fluticasone propionate combination product improves asthma control compared with the individual products in asthmatics treated with PRN short-acting beta2-agonists alone. Am J Respir Crit Care Med 2000; 161 (3 part 2; Suppl 1): A196
Nelson HS, Wolfe JD, Gross G, Greos LS, Baitinger L, Scott C, Dorinsky P. Efficacy and safety of fluticasone propionate 44mcg/salmeterol 21mcg administered in a hydrofluoroalkane (HFA) metered dose inhaler as an initial asthma maintenance treatment. Ann Allergy Asthma Immunol 2003; 91: 263-269
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
Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomized, double-blind, placebo-controlled trial. Kavuru, M., Melamed, J., Gross, G., Laforce, C., House, K., Prillaman, B., Baitinger, L., Woodring, A., and Shah, T. J Allergy Clin Immunol 2000; 105(6 Pt 1):1108-16
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
December 1998 to August 1999
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
1999-07-08
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
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