RT Journal Article
T1 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).
A1 Ojeda, Pedro
A1 Piqué, Núria
A1 Alonso, Alicia
A1 Delgado, Julio
A1 Feo, Francisco
A1 Igea, Juan Manuel
A1 Navarro, Ana
A1 Olaguibel, José María
A1 Subiza, Javier
A1 Nieto, Carles
A1 Andersson, Morgan
K1 Allergic rhinitis
K1 Rhinoconjunctivitis
K1 Allergen avoidance
K1 Barrier measures
K1 Corticosteroids use
K1 Nasal symptoms
K1 Natural pollen exposure
K1 Quality of life
K1 Efficacy
K1 Safety
K1 Alérgenos
K1 Betula
K1 Método Doble Ciego
K1 Ésteres
K1 Poaceae
K1 Árboles
AB 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.
PB BioMed Central
SN 1710-1484
YR 2013
FD 2013-08-27
LK http://hdl.handle.net/10668/2313
UL http://hdl.handle.net/10668/2313
LA en
NO Ojeda P, Piqué N, Alonso A, Delgado J, Feo F, Igea JM, et al. 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). Allergy Asthma Clin Immunol. 2013; 9(1):32
NO Journal Article;
DS RISalud
RD Apr 9, 2025