Dataset Information

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. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01478425.

SUBMITTER: Ojeda P

PROVIDER: S-EPMC3766093 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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).

Ojeda Pedro P Piqué Núria N Alonso Alicia A Delgado Julio J Feo Francisco F Igea Juan Manuel JM Navarro Ana A Olaguibel José María JM Subiza Javier J Nieto Carles C Andersson Morgan M

Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology 20130827 1

<h4>Background</h4>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.<h4>Methods</h4>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 polle ...[more]

PMID: 23981504

Similar Datasets

Project description:BackgroundAllergic rhinitis (AR) is an IgE-mediated inflammatory disease. Current conventional therapies for AR are unsatisfactory. Acupuncture has been recommended as an optional treatment for AR patients who are interested in non-pharmacotherapy in the new clinical practice guidelines for AR. Acupressure is a sub-type of acupuncture which is non-invasive with a low risk and can be self-administered. However, the current limited evidence is compromised by the high risk of bias and heterogeneity of methodology. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. This proposed RCT aims to evaluate the efficacy and safety of self-administered acupressure for the management of AR.Methods/designWe have designed a randomized, single-blind, non-specific controlled, two-arm, parallel clinical trial involving a 2-week run-in period, a 4-week intervention period and an 8-week follow-up period. The eligible participants will be randomized into either a specific or a non-specific acupressure group. They will be required to perform self-administered acupressure on either five specific acupressure points or five non-specific acupressure points, 1 min for each point, twice a day for 4 weeks. Participants will be asked to complete self-administered questionnaires for outcome measures including a 7-point scale of symptom severity, the Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQs), relief medication scores, adverse events and participants' opinion of this study at the different assessment points throughout the trial period. Data will be analyzed by the chi-square or t test using Statistical Package for Social Science (SPSS) software.DiscussionThe findings from this study should provide scientific evidence for the efficacy and safety of self-administered acupressure for the management of AR. This study may assist the development of a non-cost, non-invasive self-management method for AR sufferers.Trial registrationAustralian and New Zealand Clinical Trials Registry (ANZCTR), ID: ACTRN12617001106325 Registered on 28 July 2017.

Project description:Background:The Allergy Patient Identification for Immunotherapy (AsPIRe) program was a parallel physician and patient survey. The objectives were to examine physician and patient perceptions of seasonal allergy symptoms and their impact on patients, and to examine patient and physician attitudes to allergen immunotherapy (AIT) for seasonal allergies. AsPIRe was led by a steering committee and received research ethics board clearance from Queen's University. Methods:Allergists (17) from across Canada enrolled in the AsPIRe program and completed an on-line survey to collect demographic information and baseline perceptions. Allergists then recruited patients and completed paper-based parallel physician and patient questionnaires. Patients received an AIT informational booklet with their questionnaire. Patients who were AIT-naïve with no contraindication to AIT and 12 years of age and older met the inclusion criteria. Results:The survey was in field from February 2018 to June 2018. A total of 141 allergist surveys and 136 patient surveys were completed. Mean age of patients was 30 years old (range 12-70). Fifty-seven percent of patients reported prior knowledge of AIT. Seventy-two percent of patients reported seasonal allergies of longer than 5 years duration and in this subset of patients, 46% were at their first allergist visit. Seventy-three percent of all patients indicated they would be likely or very likely to try sublingual immunotherapy (SLIT), if recommended by their allergist compared to 36% for subcutaneous immunotherapy (SCIT). Conversely, 10% of patients reported they would be unlikely or very unlikely to try SLIT compared to 46% of patients who would be unlikely or very unlikely to try SCIT if recommended by their allergist. Conclusions:In this particular study cohort, there was a gap in perception between allergists and their patients as to the impact of allergy symptoms on daily life. Patients reported being more frequently impacted vs. their physician's assessment. When asked about preference for AIT options, Canadian patients reported they were more likely to follow their allergists' recommendation for initiation of SLIT compared to SCIT.

Project description:IntroductionAlthough recent studies have shown that the human microbiome is involved in the pathogenesis of allergic diseases, the impact of microbiota on allergic rhinitis (AR) and non-allergic rhinitis (nAR) has not been elucidated. The aim of this study was to investigate the differences in the composition of the nasal flora in patients with AR and nAR and their role in the pathogenesis.MethodFrom February to September 2022, 35 AR patients and 35 nAR patients admitted to Harbin Medical University's Second Affiliated Hospital, as well as 20 healthy subjects who underwent physical examination during the same period, were subjected to 16SrDNA and metagenomic sequencing of nasal flora.ResultsThe microbiota composition of the three groups of study subjects differs significantly. The relative abundance of Vibrio vulnificus and Acinetobacter baumanni in the nasal cavity of AR patients was significantly higher when compared to nAR patients, while the relative abundance of Lactobacillus murinus, Lactobacillus iners, Proteobacteria, Pseudomonadales, and Escherichia coli was lower. In addition, Lactobacillus murinus and Lacttobacillus kunkeei were also negatively correlated with IgE, while Lacttobacillus kunkeei was positively correlated with age. The relative distribution of Faecalibacterium was higher in moderate than in severe AR patients. According to KEGG functional enrichment annotation, ICMT(protein-S-isoprenylcysteine O-methyltransferase,ICMT) is an AR microbiota-specific enzyme that plays a role, while glycan biosynthesis and metabolism are more active in AR microbiota. For AR, the model containing Parabacteroides goldstemii, Sutterella-SP-6FBBBBH3, Pseudoalteromonas luteoviolacea, Lachnospiraceae bacterium-615, and Bacteroides coprocola had the highest the area under the curve (AUC), which was 0.9733(95%CI:0.926-1.000) in the constructed random forest prediction model. The largest AUC for nAR is 0.984(95%CI:0.949-1.000) for the model containing Pseudomonas-SP-LTJR-52, Lachnospiraceae bacterium-615, Prevotella corporis, Anaerococcus vaginalis, and Roseburia inulinivorans.ConclusionIn conclusion, patients with AR and nAR had significantly different microbiota profiles compared to healthy controls. The results suggest that the nasal microbiota may play a key role in the pathogenesis and symptoms of AR and nAR, providing us with new ideas for the treatment of AR and nAR.

Dataset Information

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).

Publications

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).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets