title: 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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01478425.
authors: Clínica de Asma y Alergia Dres, Ojeda, Oquendo, 23, 20006 Madrid, Spain. pedro.ojeda@clinicaojeda.es.
authors: Pedro
authors: P
authors: Ojeda
authors: Núria
authors: N
authors: Piqué
authors: Alicia
authors: A
authors: Alonso
authors: Julio
authors: J
authors: Delgado
authors: Francisco
authors: F
authors: Feo
authors: Juan Manuel
authors: JM
authors: Igea
authors: Ana
authors: A
authors: Navarro
authors: José María
authors: JM
authors: Olaguibel
authors: Javier
authors: J
authors: Subiza
authors: Carles
authors: C
authors: Nieto
authors: Morgan
authors: M
authors: Andersson
references: Adv Ther. 2003 Jul-Aug;20(4):213-9
references: 14669817
references: J Am Osteopath Assoc. 2002 Jun;102(6 Suppl 2):S7-14
references: 12090644
references: Pediatr Allergy Immunol. 2011 Sep;22(6):594-9
references: 21645117
references: J Allergy Clin Immunol. 2010 Sep;126(3):466-76
references: 20816182
references: Acta Otolaryngol. 2008 Jun;128(6):666-9
references: 18568502
references: Pediatr Allergy Immunol. 2005 Feb;16(1):91-2
references: 15693919
references: Basic Clin Pharmacol Toxicol. 2011 Feb;108(2):146-8
references: 21231989
references: Curr Med Res Opin. 2007 Oct;23(10):2423-31
references: 17767803
references: Clin Exp Allergy. 2000 Jan;30(1):132-40
references: 10606940
references: Allergy. 2007 Dec;62(12):1372-8
references: 17983372
references: Int Immunopharmacol. 2011 Nov;11(11):1646-62
references: 21784174
references: Curr Med Res Opin. 2006 Feb;22(2):275-85
references: 16466599
references: Eur J Pharm Sci. 1998 Jul;6(3):231-9
references: 9795071