Ojeda, PedroPiqué, NúriaAlonso, AliciaDelgado, JulioFeo, FranciscoIgea, Juan ManuelNavarro, AnaOlaguibel, José MaríaSubiza, JavierNieto, CarlesAndersson, Morgan2016-08-082016-08-082013-08-27Ojeda 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):321710-1484http://hdl.handle.net/10668/2313Journal Article;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.enAllergic rhinitisRhinoconjunctivitisAllergen avoidanceBarrier measuresCorticosteroids useNasal symptomsNatural pollen exposureQuality of lifeEfficacySafetyAlérgenosBetulaMétodo Doble CiegoÉsteresPoaceaeÁrbolesMedical Subject Headings::Named Groups::Persons::Age Groups::AdultMedical Subject Headings::Chemicals and Drugs::Biological Factors::Antigens::AllergensMedical Subject Headings::Organisms::Eukaryota::Plants::Viridiplantae::Streptophyta::Embryophyta::Angiosperms::Betulaceae::BetulaMedical Subject Headings::Organisms::Eukaryota::Plants::Viridiplantae::Streptophyta::Embryophyta::Angiosperms::BetulaceaeMedical Subject Headings::Disciplines and Occupations::Social Sciences::DemographyMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Double-Blind MethodMedical Subject Headings::Chemicals and Drugs::Organic Chemicals::Carboxylic Acids::EstersMedical Subject Headings::Chemicals and Drugs::Organic Chemicals::Alcohols::Sugar Alcohols::GlycerolMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Organisms::Eukaryota::Plants::Viridiplantae::Streptophyta::Embryophyta::Angiosperms::Oleaceae::OleaMedical Subject Headings::Health Care::Health Services Administration::Organization and Administration::Public Relations::Consumer Satisfaction::Patient SatisfactionMedical Subject Headings::Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Personal SatisfactionMedical Subject Headings::Organisms::Eukaryota::Plants::Viridiplantae::Streptophyta::Embryophyta::Angiosperms::PoaceaeMedical Subject Headings::Anatomy::Plant Structures::Plant Components, Aerial::Flowering Tops::Flowers::Germ Cells, Plant::PollenMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Data Collection::QuestionnairesMedical Subject Headings::Phenomena and Processes::Physical Phenomena::Time::Periodicity::SeasonsMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment OutcomeMedical Subject Headings::Organisms::Eukaryota::Plants::TreesMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Data Collection::Surveys and QuestionnairesMedical Subject Headings::Diseases::Respiratory Tract Diseases::Nose Diseases::Rhinitis::Rhinitis, Allergicresearch article23981504open access10.1186/1710-1492-9-321710-1492PMC3766093