Last updated: 11/07/2018 16:54:23

A double-blind, double-dummy, randomized, parallel group comparison of the efficacy and safety of fluticasone propionate aqueous nasal spray 200mcg QD versus terfenadine 60mg BID versus placebo for two weeks in patients with seasonal allergic rhinitis in the mountain cedar season.

GSK study ID
FLN-401
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A double-blind, double-dummy, randomized, parallel group comparison of the efficacy and safety of fluticasone propionate aqueous nasal spray 200mcg QD versus terfenadine 60mg BID versus placebo for two weeks in patients with seasonal allergic rhinitis in the mountain cedar season.
Trial description: A double-blind, double-dummy, randomized, parallel group comparison of the efficacy and safety of fluticasone propionate aqueous nasal spray 200mcg QD versus terfenadine 60mg BID versus placebo for two weeks in patients with seasonal allergic rhinitis in the mountain cedar season.
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:
Kozma CM, Schulz RM, Sclar DA, et al. A comparison of costs and efficacy of fluticasone propionate aqueous nasal spray (FP) and terfenadine tablets. Annals of Allergy 1994;72:58 (abstract);
van Bavel J, Findlay S, Hampel F, et al. Intranasal fluticasone propionate once daily is more effective than terfenadine twice daily in relieving symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol 1992;89:302 (abstract);
van Bavel J, Findlay SR, Hampel FC, et al. Intranasal fluticasone propionate is more effective than terfenadine tablets for seasonal allergic rhinitis. Arch Intern Med 1994;154:2699-2704
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
December 1990 to March 1991
Type
Not applicable
Phase
4

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

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
1991-20-03

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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