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)
(2013) In Allergy Asthma and Clinical Immunology 9.- 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... (More)
- 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. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/4417508
- author
- organization
- publishing date
- 2013
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Allergic rhinitis, Rhinoconjunctivitis, Allergen avoidance, Barrier, measures, Corticosteroids use, Nasal symptoms, Natural pollen exposure, Quality of life, Efficacy, Safety
- in
- Allergy Asthma and Clinical Immunology
- volume
- 9
- article number
- 32
- publisher
- BioMed Central (BMC)
- external identifiers
-
- wos:000332411400001
- scopus:84883517901
- pmid:23981504
- ISSN
- 1710-1492
- DOI
- 10.1186/1710-1492-9-32
- language
- English
- LU publication?
- yes
- id
- 4fe2182f-6282-4628-9c75-a791210705ec (old id 4417508)
- date added to LUP
- 2016-04-01 14:41:32
- date last changed
- 2022-03-22 01:24:08
@article{4fe2182f-6282-4628-9c75-a791210705ec,
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.}},
author = {{Ojeda, Pedro and Pique, Nuria and Alonso, Alicia and Delgado, Julio and Feo, Francisco and Manuel Igea, Juan and Navarro, Ana and Maria Olaguibel, Jose and Subiza, Javier and Nieto, Carles and Andersson, Morgan}},
issn = {{1710-1492}},
keywords = {{Allergic rhinitis; Rhinoconjunctivitis; Allergen avoidance; Barrier; measures; Corticosteroids use; Nasal symptoms; Natural pollen exposure; Quality of life; Efficacy; Safety}},
language = {{eng}},
publisher = {{BioMed Central (BMC)}},
series = {{Allergy Asthma and Clinical Immunology}},
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)}},
url = {{https://lup.lub.lu.se/search/files/4113332/4882668}},
doi = {{10.1186/1710-1492-9-32}},
volume = {{9}},
year = {{2013}},
}