Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis
Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray. 1. Introduction Allergic rhinitis is a common disease with estimated 600 million patients suffering from this disease worldwide [1]. According to a large scale investigation, about 20% of the European population suffers from allergic rhinitis [2] and numbers are increasing, particularly in industrial states. Although not being a life-threatening disease, allergic rhinitis has a considerable impact on general well-being and work/school performance, and particularly its impact on comorbidities such as, for example, asthma reflects the need for good treatment options. A number of pharmacological treatments against allergic rhinitis exist, such as antihistamines, leukotriene receptor agonists, mast cell stabilizing agents, and glucocorticosteroids. According to the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines, intranasal glucocorticosteroids are recommended as pharmacological treatment of allergic rhinitis and should be prescribed preferable to intranasal antihistamines and oral leukotriene receptor agonists [1]. However, many patients have reservations to use corticosteroids, and phobia of their usage can result in bad compliance [3]. This
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