Effects of intranasal salmeterol and fluticasone given alone and in combination in persistent allergic rhinitis

Background: (beta(2)-Agonists have previously been shown to be effective inhibitors of mediator release from airway mucosal mast cells.

Objective: To evaluate the effects of intranasal salmeterol and fluticasone propionate alone and in combination on the response to nasal adenosine monophosphate (AMP) challenge to assess mast cell activation.

Methods: Twenty-three patients with persistent allergic rhinitis completed a randomized, double-blind, placebo-controlled, 4-way crossover trial. They received once daily treatment with placebo, salmeterol, 50 mu g, fluticasone propionate, 500 mu g, or fluticasone propionate and salmeterol combination, 500/50 mu g, delivered via an antistatic spacer with nasal adapter for 1 week each, with trough measurements being made 12 hours after the first and last dose. The primary outcome was the maximum percentage decrease in peak nasal inspiratory flow after nasal AMP challenge.

Results: For the primary outcome there was significant protection after single and long-term dosing with fluticasone alone and fluticasone-salmeterol combination, whereas salmeterol alone only afforded protection after the first dose. Fluticasone-salmeterol combination and fluticasone but not salmeterol conferred significant chronic dosing effects on secondary outcomes of nasal symptoms and disease-specific quality of life. There was no potentiation of the response to fluticasone by salmeterol on any outcomes when given in combination.

Conclusion: Chronic dosing with fluticasone but not salmeterol confers anti-inflammatory activity against nasal AMP challenge, but there was no potentiation of fluticasone when given in combination with salmeterol. Thus, salmeterol may not be an effective treatment for use in allergic rhinitis.

Trial Registration: clinicaltrials.gov Identifier: NCT01388595. (C) 2012 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.