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)

Abstract

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 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.

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 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.

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.

Figures

Figure 1

Flow diagram of the clinical trial progress. Safety Set (SS): Randomized patients who took at least one dose of the study treatment; Full Analysis Set (FAS): randomized patients who met all selection criteria and had a value of the mini-RQLQ at baseline (visit 1); Per Protocol Set (PPS): FAS patients who completed the study treatment, did not take prohibited medications and who had a value for the primary variable (mini-RQLQ at visit 2).

Figure 2

Allergic symptoms. Allergic symptoms recorded in the patient’s diary as daily means (FAS and PPS populations).

Figure 3

Patient’s quality of life. Results of quality of life, global and in the different dimensions of the mini-RQLQ questionnaire (FAS and PPS population).