期刊论文详细信息
Allergy, Asthma & Clinical Immunology
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)
Pedro Ojeda5  Núria Piqué11  Alicia Alonso10  Julio Delgado9  Francisco Feo3  Juan Manuel Igea4  Ana Navarro8  José María Olaguibel7  Javier Subiza6  Carles Nieto2  Morgan Andersson1 
[1] Department of Otorhinolaryngology, Head & Neck Surgery, Skåne University Hospital, Ole Römers väg, 3, 22363 Lund, Sweden
[2] Reig Jofré Group, S.A., Gran Capità, 6, 08970 Sant Joan Despí, Barcelona, Spain
[3] Department of Allergy, University Hospital of Ciudad Real, Obispo Rafael Rorija, 13005 Ciudad Real, Spain
[4] Alergoasma Clinic, Pinto, 2-18, 37001 Salamanca, Spain
[5] Clínica de Asma y Alergia Dres, Ojeda, Oquendo, 23, 20006 Madrid, Spain
[6] Clínica Subiza de Asma y Alergia, General Pardinas, 116, 28006 Madrid, Spain
[7] Allergy Department, Complejo Hospitalario de Navarra, Irunlarrea, 3, 31008 Pamplona, Spain
[8] Hospital Nuestra Señora de Balme, Ambrosio de la Cuesta, 11, Seville, Spain
[9] Department of Allergy, University Hospital Virgen Macarena, Av. Dr. Fedriani, 3, 41071 Seville, Spain
[10] Clínica Paracelso Médico Quirúrgica, General Ruiz, 4, 47004 Valladolid, Spain
[11] Department of Microbiology and Parasitology, Pharmacy Faculty, Universitat de Barcelona, Av. Joan XXIII, 31, 08028 Barcelona, Spain
关键词: Safety;    Efficacy;    Quality of life;    Natural pollen exposure;    Nasal symptoms;    Corticosteroids use;    Barrier measures;    Allergen avoidance;    Rhinoconjunctivitis;    Allergic rhinitis;   
Others  :  792180
DOI  :  10.1186/1710-1492-9-32
 received in 2013-04-14, accepted in 2013-07-25,  发布年份 2013
PDF
【 摘 要 】

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

【 授权许可】

   
2013 Ojeda et al.; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20140705024900807.pdf 308KB PDF download
Figure 3. 102KB Image download
Figure 3. 112KB Image download
Figure 1. 60KB Image download
【 图 表 】

Figure 1.

Figure 3.

Figure 3.

【 参考文献 】
  • [1]Mandhane SN, Shah JH, Thennati R: Allergic rhinitis: an update on disease, present treatments and future prospects. Int Immunopharmacol 2011, 11:1646-1662.
  • [2]Willsie SK: Improved strategies and new treatment options for allergic rhinitis. J Am Osteopath Assoc 2002, 102:S7-S14.
  • [3]Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schünemann HJ: Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol 2010, 126:466-476.
  • [4]Åberg N, Dahl Å, Benson M: A nasally applied cellulose powder in seasonal allergic rhinitis (SAR) in children and adolescents; reduction of symptoms and relation to pollen load. Paediatric Allergy Immunol 2011, 22:594-599.
  • [5]Andersson M, Greiff L, Wollmer P: Nasal treatment with a microemulsion reduces allergen challenge-induced symptoms and signs of allergic rhinitis. Acta Otolaryngol 2008, 128:666-669.
  • [6]Andersson M, Greiff L, Wollmer P: Effects of a topical microemulsion in house dust mite allergic rhinitis. Basic Clin Pharmacol Toxicol 2011, 108:146-148.
  • [7]Valero A, Alonso J, Antépara I, Baró E, Colás C, del Cuvillo A, Ferrer M, Herdman M, Marti-Guadaño E, Monclús L, Navarro-Pulido AM, Sastre J, Izquierdo I, Mullol J: Health-related quality of life in allergic rhinitis: comparing the short form ESPRINT-15 and MiniRQLQ questionnaires. Allergy 2007, 62:1372-1378.
  • [8]Juniper EF, Thompson AK, Ferrie PJ, Roberts JN: Development and validation of the mini Rhinoconjunctivitis Quality of Life Questionnaire. Clin Exp Allergy 2000, 30:132-140.
  • [9]Garavello W, Romagnoli M, Gaini RM: Hypertonic or isotonic saline for allergic rhinitis in children. Pediatr Allergy Immunol 2005, 16:91-92.
  • [10]Nielsen LS, Schubert L, Hansen J: Bioadhesive drug delivery systems. I. Characterisation of mucoadhesive properties of systems based on glyceryl mono-oleate and glyceryl monolinoleate. Eur J Pharm Sci 1998, 6:231-239.
  • [11]Josling P, Steadman S: Use of cellulose powder for the treatment of seasonal allergic rhinitis. Adv Ther 2003, 20:213-219.
  • [12]Emberlin JC, Lewis RA: A double blind, placebo controlled trial of inert cellulose powder for the relief of symptoms of hay fever in adults. Curr Med Res Opin 2006, 22:275-285.
  • [13]Emberlin JC, Lewis RA: A double blind, placebo-controlled crossover trial cellulose powder by nasal provocation with Der p1 and Der f1. Curr Med Res Opin 2007, 23:2423-31.
  文献评价指标  
  下载次数:26次 浏览次数:20次