Fluticasone furoate versus placebo in symptoms of grass-pollen allergic rhinitis induced by exposure in the Vienna Challenge Chamber.
OBJECTIVE
The Vienna Challenge Chamber (VCC) offers a controlled and controllable paradigm in which to reproducibly evaluate the efficacy of anti-allergic treatment. The aim of this study was to assess the efficacy of the novel intranasal corticosteroid fluticasone furoate (FF) in the VCC.


METHODS
The single-centre, randomised, double-blind, placebo-controlled, two-period crossover study was conducted in 59 adult males with grass pollen allergic rhinitis (AR). Patients received either Fluticasone furoate 200 mcg once-daily, or placebo intranasally for 8 days. AR symptoms were induced during 4-hour allergen challenges with grass pollen in the VCC at the end of each 8-day treatment period. A first challenge was conducted at 1-5 hours post-dose, followed by a second challenge at 22-26 hours post-dose. The primary endpoint was total nasal symptom score (TNSS; sum of itch, sneeze, rhinorrhoea, obstruction symptoms assessed on a categorical scale of 0-3) weighted mean over 2-5 hours post-dose. Secondary endpoints included: TNSS weighted mean over 23-26 hours post-dose and global symptom score, eye symptom score, nasal secretions and nasal airflow weighted means over 2-5 and 23-26 hours post-dose.


RESULTS
Fluticasone furoate showed consistent attenuation of AR symptoms in both the early and late challenges. Compared with placebo, weighted mean of TNSS was reduced on average by 4.14 point-scores at 2-5 hours post-dose and 3.63 point scores at 23-26 hours post-dose. These positive effects were also seen across all secondary endpoints.


CONCLUSIONS
An 8-day treatment course of intranasal FF 200 mcg given once-daily statistically significantly reduced symptoms of AR including associated eye symptoms. Statistical significance was declared where the relevant two-sided 95% confidence interval did not contain zero. This positive effect was sustained over 24 hours suggesting that fluticasone furoate could be efficacious as a once daily steroid.
Zieglmayer
Petra
P
ENT University Clinic, Vienna, Austria. petra@zieglmayer.at
Zieglmayer
René
R
Bareille
Philippe
P
Rousell
Vicki
V
Salmon
Emma
E
Horak
Friedrich
F
D000293:Adolescent; D000328:Adult; D000730:Androstadienes / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004781:Environmental Exposure / Q000009:adverse effects*; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D006109:Poaceae / Q000009:adverse effects; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome
D000730:Androstadienes; D005938:Glucocorticoids; C523187:fluticasone furoate