Computational protocol: 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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Protocol publication

[…] On day 0 (Visit 1) patients were asked to participate in the study, and upon signing the informed consent form and patient information, they were allocated to one of the study groups, without any washout period. Antiallergic medications used the last two days prior to inclusion were recorded by the physician. Patients were treated either with ectoine containing nasal spray and eye drops or with azelastine containing nasal spray and eye drops. Patients of the ectoine group had to apply one eye drop per eye and one puff of the nasal spray per nostril four times per day. Patients of the azelastine group had to apply one eye drop per eye and one puff of the nasal spray per nostril twice per day. The treatment period was 7 days, and patients were asked to document their symptoms, together with possible comedication and adverse effects daily in patient diaries at the evening. Therefore the patients' assessments started after the products had been applied already. Following treatment, patients came back for Visit 2 (day 7), during which symptom scores were evaluated and tolerability, efficacy and compliance, and possibly comedications, antiallergic and others, were assessed. In- and Exclusion Criteria. Male or female patients aged 18–70 with proven allergy and acute symptoms in nose and eye (sum nasal score ≥ 15 and sum oral score ≥ 6) were allowed to take part in the study. Allergy diagnosis was based on positive prick test. Exclusion criteria were pregnant and nursing women, drug addicts and persons unable to give consent to study participation, patients with intolerance against ingredients of any of the study treatments, previous eye or nose surgery, concomitant treatment with antiallergic drugs, and diseases which might influence the output of the study according to the physicians' judgment. Scoring of Nasal and Ocular Symptoms. Single nasal (nasal obstruction, rhinorrhea, and sneezing) and ocular symptoms (eye itching, tearing, and conjunctivitis) were scored with an 8 point scale ranging from no symptoms (0) to very severe symptoms (8). Scoring of Efficacy, Tolerability, and Compliance. Efficacy, tolerability, and compliance were judged by using a scale ranging from 0 (very good) to 8 (bad). Thus, a general judgment, of either how well to tolerate or how efficient the products were, had to be given by the patients and documented in the patient diaries. Both scoring values were based on the patients' personal opinion/feeling with the products. Whereas efficacy and tolerability were assessed both by patients and by physicians, compliance was solely judged by physicians. Statistics. The statistical analysis was carried out with SPSS version 18 and SigmaPlot version 12. Both efficacy and safety analyses were performed on the entire study population. Descriptive statistics were used for a quantitative report of the main study population features. Continuous variables were tested for normal distribution via Kolmogorov-Smirnov test. Further analysis was carried out with the Mann-Whitney U test, Wilcoxon test, or Friedman test. The level of significance was set to P < 0.05 in all tests. Unavailable data were treated as “missing values” or substituted by the “last value carried forward” method. […]

Pipeline specifications

Software tools SPSS, SigmaPlot
Application Miscellaneous
Organisms Homo sapiens
Diseases Rhinitis, Allergic, Seasonal
Chemicals Cromolyn Sodium