Fluticasone furoate versus placebo in symptoms of grass-pollen allergic rhinitis induced by exposure in the Vienna Challenge Chamber
- 17 April 2008
- journal article
- research article
- Published by Informa Healthcare in Current Medical Research and Opinion
- Vol. 24 (6), 1833-1840
- https://doi.org/10.1185/03007990802155792
Abstract
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. Conclusion: 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.Keywords
This publication has 16 references indexed in Scilit:
- Optimal dose selection of fluticasone furoate nasal spray for the treatment of seasonal allergic rhinitis in adults and adolescentsAllergy and Asthma Proceedings, 2007
- The role of allergen challenge chambers in the evaluation of anti-allergic medication: an international consensus paperClinical & Experimental Allergy Reviews, 2006
- Levocetirizine has a longer duration of action on improving total nasal symptoms score than fexofenadine after single administrationBritish Journal of Clinical Pharmacology, 2005
- Efficacy and Safety of an Oral Formulation of Cetirizine and Prolonged-Release Pseudoephedrine versus Budesonide Nasal Spray in the Management of Nasal Congestion in Allergic RhinitisTreatments in Respiratory Medicine, 2005
- Comparison of the effects of desloratadine 5‐mg daily and placebo on nasal airflow and seasonal allergic rhinitis symptoms induced by grass pollen exposureAllergy, 2003
- Effect of desloratadine versus placebo on nasal airflow and subjective measures of nasal obstruction in subjects with grass pollen–induced allergic rhinitis in an allergen-exposure unitJournal of Allergy and Clinical Immunology, 2002
- Comparative onset of action and symptom relief with cetirizine, loratadine, or placebo in an environmental exposure unit in subjects with seasonal allergic rhinitis: confirmation of a test systemAnnals of Allergy, Asthma & Immunology, 2001
- Controlled comparison of the efficacy and safety of cetirizine 10 mg o.d. and fexofenadine 120 mg o.d. in reducing symptoms of seasonal allergic rhinitis.International Archives of Allergy and Immunology, 2001
- Efficacy and safety relative to placebo of an oral formulation of cetirizine and sustained‐release pseudoephedrine in the management of nasal congestionAllergy, 1998
- The human pharmacology of fluticasone propionateRespiratory Medicine, 1990