bitop AG, a biotech company specialising in the development of Ectoin-containing medical devices, reports that Ectoin allergy nasal spray has been shown to significantly reduce symptoms of acute allergic rhinitis in a two-week observational, randomized, comparative crossover study with 50 patients suffering from acute allergic rhinitis. Based on this study, bitop performed a clinical trial on eyes drops and nasal spray in humans using an environmental exposure chamber (EEC) model. The preliminary outcomes suggest a significant improvement of the symptoms of allergic rhinitis and conjunctivitis.
Patients used either Ectoin allergy nasal spray or cromoglycinate nasal spray. After one week of treatment, a crossover between the groups was performed with a subsequent one-week treatment. Levels of allergic symptoms were monitored both by physicians and patients using a combined nasal and non-nasal symptom score. The nasal symptom score included congestion, rhinorrhea and errhine.
Both nasal sprays produced significant improvement of all nasal symptoms during the first week of treatment. During the second week, after the groups changed medication, further improvement was observed with both sprays. However, for both products, reduction of the symptoms was not as pronounced as in the first week. The study results indicate that the Ectoin-containing nasal spray is effective in alleviating symptoms of allergic rhinitis.
"Ectoin allergy nasal spray has a significant effect in patients with allergic rhinitis. Since this effect was comparable to established medicines, we suggest that Ectoin- containing medical devices are a new option for the treatment of allergic symptoms. Preliminary results of the EEC study support this notion,” says Dr Dirk Probst CEO at bitop AG.
According to the ratings of both physicians and patients, Ectoin allergy nasal spray was significantly better tolerated than cromoglycinate spray. No adverse reactions have been reported with the Ectoin spray in this study. Patients who first received cromoglycinate spray rated Ectoin allergy nasal spray as being even more effective, indicating that the treatment with Ectoin allergy nasal spray has advantages.
The clinical trial in the EEC has been successfully completed. The results of the study in patients with allergic rhinitis and allergic conjunctivitis are currently being analyzed and are expected to be published in autumn 2010.