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PMID: 19463202 Published · ppublish English Clinical Trial Journal Article Multicenter Study Randomized Controlled Trial

Weather/temperature-sensitive vasomotor rhinitis may be refractory to intranasal corticosteroid treatment.

Allergy and asthma proceedings ·Vol. 30 ·No. 2 ·2009-00-00 ·Pages 120-7

Jacobs R, Lieberman P, Kent E, Silvey M, Locantore N, Philpot EE

Abstract

Vasomotor rhinitis (VMR) is a common but poorly understood disorder of which there are two major subgroups: VMR(w/t), triggered by weather/temperature and VMR(ir), triggered by airborne irritants. No specific biological pathways or specific treatments for VMR(w/t) or VMR(ir) have been identified. However, intranasal corticosteroids (INSs) are effective in treating many forms of nonallergic rhinitis that include these conditions. A recently introduced INS with established efficacy in allergic rhinitis and enhanced affinity, fluticasone furoate, may possess the potency and safety profile required to treat chronic VMR(w/t). Two replicate studies (FFR30006 and FFR30007) were conducted in six countries to evaluate the efficacy and safety of fluticasone furoate nasal spray in subjects with VMR(w/t). After a 7- to 14-day screening period, subjects (n = 699) with symptomatic VMR(w/t) received fluticasone furoate, 110 mug q.d. or placebo for 4 weeks in these two randomized, double-blind, parallel-group studies. Subjects rated their nasal symptoms (congestion, rhinorrhea, and postnasal drip) twice daily on a 4-point categorical scale and evaluated their overall response to treatment at study end. Fluticasone furoate did not significantly improve daily reflective total nasal symptom scores, the primary end point, versus placebo (p = 0.259) and there was no improvement in any other measure of efficacy. The active treatment was well tolerated. Fluticasone furoate was not effective in treating subjects with a newly defined condition, weather-sensitive VMR. These unexpected results suggest that VMR(w/t) is a distinct subgroup of VMR that is refractory to treatment with INSs. Additional study of other treatments for VMR(w/t) (including INSs) is warranted.

MeSH Terms
Administration, Intranasal Adolescent Adult Aged Aged, 80 and over Androstadienes/administration & dosage,adverse effects Canada Child Drug Resistance/immunology Europe Female Humans Male Middle Aged Nasal Obstruction/drug therapy,immunology Rhinitis, Vasomotor/drug therapy,epidemiology,etiology,physiopathology Temperature Treatment Outcome United States Weather
Chemicals
Androstadienes fluticasone furoate
Authors & Affiliations
6 authors, click to expand affiliations / ORCID
Jacobs Robert
Biogenics Research Institute, San Antonio, Texas 78229, USA. [email protected]
Lieberman Philip
Kent Edward
Silvey MaryJane
Locantore Nicholas
Philpot Edward E
Article Info
Journal
Allergy and asthma proceedings
Abbr.
Allergy Asthma Proc
ISSN
1088-5412
Published
2009-00-00
Pages
120-7
Language
English
Region
United States
NLM ID
9603640
Subset
IM
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