This is a prospective, national, randomized, multicenter, parallel group, Phase III study that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray twice a day against azelastine into both nostrils during a 28-day follow-up period.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* To be diagnosed as allergic rhinitis on the basis of medical history, physical examination, and skin prick test, and according to ARIA 2008 criteria
* To be included in seasonal and perennial allergic rhinitis group
* To have a related complaint for at least 2 years
* To be informed about the study and to give consent to participate in the study
Exclusion Criteria:
* Diagnosis of superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration and nasal septum perforation during nasal examination
* Presence of nasal diseases that are likely to affect the accumulation of intranasal drugs, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis or clinically significant nasal structural abnormalities
* Having undergone a nasal or sinus surgery for up to one year before the study
* The use of systemic or topical steroids within the last 15 days prior to inclusion in the study
* The use of antihistamine, chromoline Na within the last 15 days prior to inclusion in the study
* The use of any investigational drug within 30 days prior to Visit 1;
* Known hypersensitivity to components of the products used in the study
* Presence of respiratory infections, which have developed within the two weeks prior to Visit 1
* Diagnosis of COPD
* A history of alcohol or drug addiction treatment within the last 2 years prior to inclusion in the study, or any current addiction on alcohol or drugs,
* Use of alc…