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Treatment of allergic rhinitis with ectoine containing nasal spray and eye drops in comparison with azelastine containing nasal spray and eye drops or with cromoglycic Acid containing nasal spray.

ABSTRACT: Objectives. Allergic rhinitis is a common disease with increasing prevalence and high impact on economic burden and comorbidities. As treatment with pharmacological drugs is not always satisfactory due to side effects and incomplete efficacy, alternative treatment strategies are needed. Ectoine is an osmolyte with membrane stabilizing and inflammation reducing capacities. Nasal spray and eye drops containing ectoine are promising new treatment regimens for allergic rhinitis sufferers. Design and Methods. The current two noninterventional trials evaluated the efficacy and safety of ectoine containing nasal spray and eye drops for treating allergic rhinitis in comparison with either azelastine or cromoglycic acid containing products. Nasal and ocular symptom developments as well as judgment of tolerability and efficacy were assessed both by investigators and patients over a time period of one to two weeks. Results. Both trials confirmed that ectoine containing products reduced nasal and ocular symptoms in allergic rhinitis patients. Results clearly demonstrated good safety profiles of the ectoine products comparable to those of azelastine and even better to those of cromoglycate products. Conclusion. Ectoine containing nasal spray and eye drops are interesting new treatment strategies for sufferers of allergic rhinitis, combining both good efficacy and absence of side effects.

SUBMITTER: Werkhauser N

PROVIDER: S-EPMC4058592 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Treatment of allergic rhinitis with ectoine containing nasal spray and eye drops in comparison with azelastine containing nasal spray and eye drops or with cromoglycic Acid containing nasal spray.

Werkhäuser Nina N Bilstein Andreas A Sonnemann Uwe U

Journal of allergy 20140601

Objectives. Allergic rhinitis is a common disease with increasing prevalence and high impact on economic burden and comorbidities. As treatment with pharmacological drugs is not always satisfactory due to side effects and incomplete efficacy, alternative treatment strategies are needed. Ectoine is an osmolyte with membrane stabilizing and inflammation reducing capacities. Nasal spray and eye drops containing ectoine are promising new treatment regimens for allergic rhinitis sufferers. Design and ...[more]

PMID: 24982680

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Project description:BackgroundPatients are often dissatisfied with the symptom control obtained from available pharmacological treatments for seasonal allergic rhinoconjunctivitis (ARC). Therefore, patients seek for alternative, nonpharmacological options to treat their symptoms. Here, we assessed the efficacy of ectoine nasal spray and ectoine eye drops in comparison to placebo to prevent nasal and ocular symptoms following exposure to pollen in patients with ARC.MethodsIn this double-blind, randomized, placebo-controlled, cross-over study, 46 patients with ARC applied ectoine eye drops and nasal spray in immediate succession or placebo eye drops and nasal spray for 13 days before ARC symptoms were induced in an environmental exposure chamber. Primary endpoint was the baseline-adjusted area under the curve (AUC) posttreatment total nasal symptom score (TNSS) and the total ocular symptom score (TOSS) using analysis of covariance. Secondary endpoints were, amongst others, total nonnasal symptoms score (TNNSS) and nasal patency (measured using acoustic rhinometry).ResultsTreatment with both ectoine and placebo reduced TNSS, TOSS, and TNNSS upon allergen exposure. The analysis of parameters at baseline and after allergen exposure demonstrated that ectoine induced a clinically relevant improvement in ARC symptoms compared to placebo: the least square mean difference for baseline-adjusted AUC was -1.87 for TNSS, -1.45 for TOSS and -2.20 for TNNSS. The mean change from baseline AUC of TNNSS for ectoine was also significantly greater than for placebo (-5.49 vs. -3.46; p = 0.011). Ectoine significantly improved the singular symptoms "sneezing," "watery eyes" and "itchy eyes" (p ≤ 0.021) as well as "itchy ear/palate" (p = 0.036) in comparison to placebo. Mean cross sectional areas of the nasal cavity were reduced to a lesser extent after treatment with ectoine (-0.020 ± 0.022) than with placebo (-0.047 ± 0.029). The current study also demonstrated a very good safety profile of ectoine treatment. Few AEs with comparable numbers in both treatment groups were reported during the study, which were mild in severity and resolved without medical treatment.ConclusionThe study suggests that ectoine is effective in reducing nasal and ocular symptoms associated with ARC. Being a natural, bacteria derived stress protection molecule functioning by a physical mode of action, it therefore represents an alternative nonpharmacological treatment option.

Project description:IntroductionThe safety and efficacy of fluticasone furoate nasal spray (FFNS) for the symptoms of seasonal and perennial allergic rhinitis have been previously demonstrated in several clinical studies. The objective of this pilot study was to compare the efficacy and safety of FFNS 110 mcg once daily with placebo in patients with irritant (non-allergic) rhinitis triggered predominantly by air pollution.MethodsThis was a randomized, double-blind, placebo-controlled, 4-week study of subjects in Thailand with irritant rhinitis who received either FFNS 110 mcg (N=53) or placebo (N=49) once-daily. Subjects with a ≥2 year history of air pollution as their predominant rhinitis trigger, negative skin test to local seasonal/perennial allergens, positive histamine skin test, and normal sinus radiograph were enrolled if they met minimum reflective total nasal symptom score (rTNSS) ≥4.5 (maximum=9) and a nasal congestion score of ≥2 (maximum =3). All were assessed for nasal eosinophilia at study entry and completion. Air quality was monitored throughout the study. The primary efficacy endpoint was the mean change from baseline over the treatment period in daily rTNSS, the average of the morning and evening rTNSS. The key secondary measure was the mean change from baseline over the entire treatment period in morning pre-dose instantaneous total nasal symptom score (iTNSS).ResultsThe Air Quality Index (AQI) during the study generally did not reach unhealthy levels. Baseline daily rTNSS scores were similar between treatment groups (FFNS=6.7; placebo=6.4). The least square mean change from baseline in rTNSS was -2.17 and -2.10 for FFNS and placebo, respectively, with a difference of -0.065 (p=0.845). Gradual improvements were seen in both treatment groups for iTNSS; however, the treatment difference (-0.075) was not statistically significant (p=0.827). Additionally, there were no statistically significant differences between treatment groups for AM and PM rTNSS, individual nasal symptoms, daily reflective, AM and PM reflective and AM pre-dose instantaneous total ocular symptom scores (TOSS) or individual ocular symptom scores. Nasal cytology at baseline found more than two-thirds of subjects had <20% eosinophils. Adverse events were few and similar between groups and noted as mild in intensity.ConclusionSubjects receiving FFNS had similar improvement to placebo in their rhinitis symptoms. The lack of a treatment effect may be in part due to the overall good air quality present throughout the study or an insufficient dose or duration of FFNS. The safety findings showed FFNS 110 mcg once daily to be well tolerated.

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

Treatment of allergic rhinitis with ectoine containing nasal spray and eye drops in comparison with azelastine containing nasal spray and eye drops or with cromoglycic Acid containing nasal spray.

Publications

Treatment of allergic rhinitis with ectoine containing nasal spray and eye drops in comparison with azelastine containing nasal spray and eye drops or with cromoglycic Acid containing nasal spray.

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