EVALUATION OF THE EFFECTIVENESS AND SAFETY OF DOSPRAY® NAZAL SPRAY IN THE SYMPTOMATIC TREATMENT OF PERSISTENT ALLERGIC RHINITIS: A POST-REGISTRATION OBSERVATION STUDY
- Conditions
- Allergic Rhinitis
- Interventions
- Other: non-interventional study
- Registration Number
- NCT05896241
- Lead Sponsor
- LeKos LLP
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Рatients on other alternative treatment = 63 non-interventional study Patients who have been prescribed other alternative treatment as part of routine medical practice Patients taking Dospray = 63 non-interventional study Patients who were prescribed Dospray as part of routine medical practice
- Primary Outcome Measures
Name Time Method Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) [Time: 7 days]
- Secondary Outcome Measures
Name Time Method 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] Adverse reactions - Number of yellow cards. [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]
Trial Locations
- Locations (2)
LLP LOR-Center Ai-Medicus
🇰🇿Almaty, Kazakhstan
Allergo Clinic Medical Center
🇰🇿Almaty, Kazakhstan