NCT05896241

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 126 (estimated)
• Sponsor: LeKos LLP · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
OTHER	non-interventional study	non-interventional study

Timeline

• Start date: 2023-05-15
• Primary completion: 2023-09-15
• Completion: 2023-12-15
• First posted: 2023-06-09
• Last updated: 2023-06-09

Locations

2 sites across 1 country: Kazakhstan