Abstract
BackgroundSince 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.MethodsRandomized, 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 or placebo 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.ResultsDemographic 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 full analysis set (FAS) and patients completing treatment (PPS) 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.ConclusionsThe topical application of the microemulsion is a feasible and safe therapy in the prevention of allergic symptoms, particularly nasal congestion.Trial registrationClinicalTrials.gov Identifier: NCT01478425
Highlights
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
Rhinorrhea, edema of the nasal mucosa, nasal mucosa pallor and crusts, eye redness and epiphora were seldom present at baseline in both groups and these findings significantly increased in both groups at visit 2
The least-squares means for the allergic symptoms recorded in the patients’ diary cards were always lower in the active group than in the control group, in both full analysis set (FAS) and Per protocol set (PPS) populations
Summary
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. With regard to allergen avoidance or modification of allergen exposure, barrier protection measures for avoiding contact with allergens, such as nose filters or nasally applied cellulose powders, are being increasingly developed and evaluated in patients with allergic rhinitis [4]. In this context, a topical microemulsion made of glycerol esters for topical application in the nose has been developed, with the aim of conferring a protective effect in patients with allergic rhinitis. The allergic reaction will be blocked by the application of the microemulsion at the very beginning of the allergic cascade, in contrast to commonly used symptomatic medications such as antihistamines or corticosteroids, which act at the end of this cascade
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