Last updated: 11/07/2018 18:50:49
A Multi-Center, Randomized, Double-Blind, Double Dummy, Parallel-Group, 12 Week Active Control Comparison of Salmeterol/Fluticasone Propionate Combination Product (50/100mcg BID) via the DISKUS inhaler with Fluticasone Propionate (100mcg BID) via the DISKUS plus Oral Montelukast (10mg QD) in Adu ...
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 Multi-Center, Randomized, Double-Blind, Double Dummy, Parallel-Group, 12 Week Active Control Comparison of Salmeterol/Fluticasone Propionate Combination Product (50/100mcg BID) via the DISKUS inhaler with Fluticasone Propionate (100mcg BID) via the DISKUS plus Oral Montelukast (10mg QD) in Adu ...
Trial description: A Multi-Center, Randomized, Double-Blind, Double Dummy, Parallel-Group, 12 Week Active Control Comparison of Salmeterol/Fluticasone Propionate Combination Product (50/100mcg BID) via the DISKUS inhaler with Fluticasone Propionate (100mcg BID) via the DISKUS plus Oral Montelukast (10mg QD) in Adu ...
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: Comparative efficacy of asthma treatments: impact of allergic vs non-allergic status on response to therapy. K. Rickard P. Dorinsky S. Yancey A. Emmett 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver CO
Abstract: Cost-effectiveness analysis of fluticasone propionate/salmeterol combination versus montelukast in the treatment of adults with asthma. ChristopherLeibman, Dev Pathak, Brian Bowers, Paul M Dorinsky, Pameia Pepsin, Chris Kalberg, Amanda Emmett, Kathleen Rickard. 58th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/1/2002 New York NY
Abstract: Incidence of asthma exacerbations by season and the effects of treatment with fluticasone propionate/salmeterol (fsc) or fluticasone propionate (fp) compared with montelukast. Nelson, H., Yancey, S., Emmett, A., Sutton, L., and Dorinsky, P. 61st Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/18/2005 San Antonio, TX; USA
Bateman ED, Akveld M, Ho M. Greater responder rate to fluticasone propionate/salmeterol combination over montelukast plus fluticasone in asthma. Am. J. Respir. Crit. Care Med. 2003;167(7 Suppl.):A367.
Kerwin E, Srebro S, Church N, Emmett A, Rickard K, Knobil K. Salmeterol added to low-dose fluticasone propionate (FP) improves pulmonary function and salbuterol use more rapidly than adding montelukast. Ann Allergy Asthma Immunol 2001; 86 (1) : 99
Nelson HS, Busse WW, Kerwin E, et al. Fluticasone propionate/salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroid plus montelukast. J. Allergy Clin. Immunol. 2000;106:1088-1095.Nelson HS, Church NL, Emmett AH, Rickard KA, Knobil K. A comparison of using fluticasone/salmeterol combination versus adding montelukast in asthma in patients experiencing symptoms on inhaled corticosteroids. Chest 2000;118 (4 Suppl): 85s
Rickard K, Dorinsky P, Yancey S, Emmett A. Comparative Efficacy of Asthma Treatments: Impact of Allergic vs. Non-allergic Status on Response to Therapy. J Allergy Clin Immunol 2003; 11 (2): S269
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
April 1999 to January 2000
Type
Not applicable
Phase
4
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
2000-28-01
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
Not applicable
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