Last updated: 11/07/2018 17:10:29
A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Two-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg every day Versus Montelukast 10mg every day in Subjects ≥15 Years Old with Seasonal Allergic Rhinitis (SAR)
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 Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Two-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg every day Versus Montelukast 10mg every day in Subjects ≥15 Years Old with Seasonal Allergic Rhinitis (SAR)
Trial description: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Two-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg every day Versus Montelukast 10mg every day in Subjects ≥15 Years Old with Seasonal Allergic Rhinitis (SAR)
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: Intranasal fluticasone propionate provided greater relief compared to oral montelukast for nasal congestion and other daytime and evening nasal symptoms of seasonal allergic rhinitis. B, G. Martin I C P. AndreWS J H. van Bave F C. Hampe E E Philpot C A. Baido K A. RiCkard 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver, CO; USA
Philpot E, Toler T, Rickard K. The enhancement of effect by an intranasal placebo spray on the efficacy of an oral allergy tablet comparator. Journal of the World Allergy Organization Supplement No. 1, 2003.
Ratner PH, Howland WC, Arastu R, Philpot EE, Klein KC, Baidoo CA, Faris MA, Rickard KA. Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast. Ann Allergy Asthma Immunol 2003;90:536-542
Ratner PH, Howland WC, Arastu R, Reed K, Simms LL, Philpot EE, Rickard KA. Fluticasone propionate aqueous nasal spray provided significantly greater improvement in nasal symptoms of seasonal allergic rhinitis compared with montelukast. Ann Allergy Asthma Immunol 2003;90:110 (abstract)
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
December 2001 to February 2002
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
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
2002-22-02
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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