Allergic Rhinitis
Conditions
Brief summary
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: 1. Patients taking Dospray = 63 2. Patients on other alternative treatment = 63 Duration of Patient Participation - 7-10 days (duration of treatment for an individual patient).
Detailed description
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: 1. Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) \[Time: 7 days\] 2. Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS) \[Time: 7 days\] 3. Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS) 4. Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms \[Time: 7 days\]. 5. Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores \[Time: 7 days\] 6. Adverse reactions \[Time: 7 days\] Number of yellow cards.
Interventions
OTHERnon-interventional study
non-interventional study
Sponsors
LeKos LLP
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) | [Time: 7 days] |
Secondary
| Measure | 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] |
Countries
Kazakhstan
Contacts
Primary ContactAigul Medeulova, MD
Backup ContactKanat Khazhidinov, MD
Outcome results
None listed