A topical microemulsion for the prevention of allergic rhinitis symptoms

Research

A topical microemulsion for the prevention of allergic rhinitis symptoms: results of a randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial (Nares study)

Pedro Ojeda, Núria Piqué, Alicia Alonso, Julio Delgado, Francisco Feo, Juan Manuel Igea, Ana Navarro, José María Olaguibel, Javier Subiza, Carles Nieto and Morgan Andersson

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Allergy, Asthma & Clinical Immunology 2013, 9:32 doi:10.1186/1710-1492-9-32

Published: 27 August 2013

Abstract (provisional)

Background

Since barrier protection measures to avoid contact with allergens are being increasingly developed, we assessed the clinical efficacy and tolerability of a topical nasal microemulsion made of glycerol esters in patients with allergic rhinitis.

Methods

Randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial in which adult patients with allergic rhinitis or rhinoconjunctivitis due to sensitization to birch, grass or olive tree pollens received treatment with topical microemulsion (ME) or placebo (SS) during the pollen seasons. Efficacy variables included scores in the mini-RQLQ questionnaire, number and severity of nasal, ocular and lung signs and symptoms, need for symptomatic medications and patients' satisfaction with treatment. Adverse events were also recorded.

Results

Demographic characteristics were homogeneous between groups and mini-RQLQ scores did not differ significantly at baseline (visit 1). From symptoms recorded in the diary cards, the ME group showed statistically significant better scores for nasal congestion (0.72 vs. 1.01; p = 0.017) and mean total nasal symptoms (0.7 vs. 0.9; p = 0.045). At visit 2 (pollen season), lower values were observed in the mini-RQLQ in the ME group, although there were no statistically significant differences between groups in both FAS (full analysis set) and PPS (patients completing treatment) populations. The results obtained in the nasal symptoms domain of the mini-RQLQ at visit 2 showed the highest difference (-0.43; 95% CI: -0.88 to 0.02) for the ME group in the FAS population. The topical microemulsion was safe and well tolerated and no major discomforts were observed. Satisfaction rating with the treatment was similar between the groups.

Conclusions

The topical application of the microemulsion is a feasible and safe therapy in the prevention of allergic symptoms, particularly nasal congestion.

Trial registration: ClinicalTrials.gov Identifier: NCT01478425

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.