EVALUATION OF THE EFFECTIVENESS AND SAFETY OF DOSPRAY® NAZAL SPRAY IN THE SYMPTOMATIC TREATMENT OF PERSISTENT ALLERGIC RHINITIS: A POST-REGISTRATION OBSERVATION STUDY

Study Overview
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Brief Summary
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The combined use of dexamethasone and oxymetazoline has a vasoconstrictive, anti-inflammatory and anti-allergic effect when applied topically in diseases of the upper respiratory tract. The main goal of this research is Evaluation of the effectiveness of Dospray® nasal spray in the treatment of persistent allergic rhinitis. The study will involve 126 patients diagnosed with allergic rhinitis: Patients taking Dospray = 63 Patients on other alternative treatment = 63 Duration of Patient Participation - 7-10 days (duration of treatment for an individual patient).

Detailed Description
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Primary task: Overall assessment of the effectiveness of Dospray® nasal spray in the treatment of persistent allergic rhinitis. Secondary Tasks: Symptomatic evaluation of the effectiveness of Dospray® nasal spray in the treatment of persistent allergic rhinitis; Evaluation of the effect of Dospray® nasal spray on conjunctive symptoms in the treatment of persistent allergic rhinitis; Evaluation of the effect of Dospray® nasal spray on the severity and frequency of nasal symptoms in the treatment of persistent allergic rhinitis; Assessment of the quality of life before and after the use of Dospray® nasal spray in the treatment of persistent allergic rhinitis; Safety assessment of the use of nasal spray Dospray®. Study Endpoints: Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) [Time: 7 days] Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS) [Time: 7 days] Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS) Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms [Time: 7 days]. Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores [Time: 7 days] Adverse reactions [Time: 7 days] Number of yellow cards.

Official Title
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EVALUATION OF THE EFFECTIVENESS AND SAFETY OF DOSPRAY® NAZAL SPRAY IN THE SYMPTOMATIC TREATMENT OF PERSISTENT ALLERGIC RHINITIS: A POST-REGISTRATION OBSERVATION STUDY

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Other: non-interventional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons aged 18 to 65 years Total TNSS score on the day of inclusion in the study equal to or greater than 4. Patients who were prescribed the drug Dospray® or other symptomatic treatment as part of routine medical practice outside the study. Voluntary desire to provide informed consent to participate in the study. Exclusion Criteria: Objective symptoms suggestive of renal, hepatic, or heart failure; Pregnant and lactating women; Patients taking systemic steroids within 30 days prior to inclusion in the study; Use of nasal sprays containing corticosteroids within 30 days prior to enrollment in the study; Patients receiving immunomodulatory therapy (including Allergen specific immunotherapy (ASIT)); Patients taking drugs for the treatment of bronchial asthma; Patients with polyps in the nasal cavity and / or deformity of the nasal septum requiring surgical correction; Infectious diseases of the upper respiratory tract within 14 days before enrollment in the study; Patients prone to nosebleeds, having glaucoma, convulsive syndrome or other neuropsychiatric pathologies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients taking Dospray = 63<br>Patients who were prescribed Dospray as part of routine medical practice | Other: non-interventional study<br>* non-interventional study<br>|
| Рatients on other alternative treatment = 63<br>Patients who have been prescribed other alternative treatment as part of routine medical practice | Other: non-interventional study<br>* non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) |  | [Time: 7 days] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS) |  | [Time: 7 days] | 
| Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS) |  | [Time: 7 days] | 
| Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms. |  | [Time: 7 days] | 
| Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores |  | [Time: 7 days] | 
| Adverse reactions - Number of yellow cards. |  | [Time: 7 days] |