Last updated: 11/07/2018 19:15:33
A Randomized, Double-Blind, Parallel-Group Trial Evaluating Safety and Efficacy of Salmeterol 50mcg BID and Fluticasone Propionate 250mcg BID Individually and in Combination and Placebo in Subjects with 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, Parallel-Group Trial Evaluating Safety and Efficacy of Salmeterol 50mcg BID and Fluticasone Propionate 250mcg BID Individually and in Combination and Placebo in Subjects with Asthma.
Trial description: A Randomized, Double-Blind, Parallel-Group Trial Evaluating Safety and Efficacy of Salmeterol 50mcg BID and Fluticasone Propionate 250mcg BID Individually and in Combination and Placebo in Subjects with 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:
Aggarwal SK, Frith LJ, Ho M, Weeks T, Ho SY. Fluticasone propionate/salmeterol delivered from a single inhaler demonstrates synergistic benefits in asthma. Am J Respir Crit Care Med 2003; 167 (7): A890
Bateman ED, Frith L, Ho M. Guideline-based asthma control reduces maximally the impact of asthma upon patient-assessed quality of life. Am J Respir Crit Care Med 2002; 165 (8): A44
Cook CK, Prillaman BA, House KW, Rickard KA, Shah TP. Concurrent use of salmeterol/fluticasone propionate Diskus powder combination product and fluticasone propionate aqueous nasal spray does not adversely affect HPA-axis function. Ann Allergy Asthma Immunol 2001;86(1): 98
Dorinsky P, Yancey S, Kral K, Emmett A, House K, Prillaman B, et al. Asthma control with salmeterol/fluticasone combination product is superior to salmeterol or inhaled steroids alone. Am J Respir Crit Care Med 2000; 161 (3 part 2 Suppl 1): A195
Edin H, Prillaman B, Baitinger LA, House KW, Shah TP. Improved ability to perform strenuous activities after treatment with fluticasone propionate/salmeterol combination. Am J Respir Crit Care Med 2002; 165 (8): A112
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
Lumry W, Windom H, Mendelson L, Pedinoff A, Prillaman B, Baitinger L, Woodring A et al. The salmeterol/fluticasone propionate (50/250 mcg) dry powder combination Diskus has a faster onset of effect compared with salmeterol or fluticasone propionate in patients with asthma. J Allergy Clin Immunol 1999; 103 (1 Part 2): S132
Lundback B, Pieters WR, Johansson G, Palmqvist M, Price MJ, Sondhi S, et al. Costeffectiveness analyses of salmeterol/fluticasone propionate combination product and fluticasone propionate in patients with asthma I: Introduction and Overview. Phamacoeconomics 1999; 16 (Suppl 2): 1-8
Markham A, Adkins JC. Inhaled salmeterol/fluticasone propionate combination: A pharmacoeconomic review of its use in the management of asthma. Pharmacoeconomics 2000; 18 (6): 591-608
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
Palmqvist M, Price MJ, Sondhi S. Cost-effectiveness analysis of salmeterol/fluticasone propionate 50/250µg vs fluticasone propionate 250µg in adults and adolescents with asthma. IV: Results. Phamacoeconomics 1999; 16 (Suppl 2): 23-28
Pearlman D, Baitinger L, Woodring A, Prillaman B, House K, Shah T. Salmeterol 50mcg/fluticasone propionate 250 mcg Diskus combination product demonstrates improvements inlung function regardless of baseline corticosteroid therapy. Am J Respir Crit Care Med 2000; 161(3 part 2; Suppl 1): A196
Pieters WR, Lundback B, Johansson G, Palmqvist M, Price MJ, Sondhi S, et al. Cost-effectiveness analyses of salmeterol/fluticasone propionate combination product and fluticasone propionate in patients with asthma. II: Study methodologies. Phamacoeconomics 1999; 16 (Suppl 2): 9-14
Reese PR, Mahajan P, Woodring A. Salmeterol/fluticasone propionate combination product improves quality of life in asthma patients. Eur Respir J 1998; 12 (Suppl 28): 35s
Stempel DA. Salmeterol/fluticasone propionate combination product in asthma - An evaluation of its cost effectiveness vs fluticasone propionate . Foreword. Phamacoeconomics 1999; 16 (Suppl 2): U6-U7
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
August 1996 to July 1997
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
1997-31-07
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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