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

Recruiting

• Conditions: Allergic Rhinitis

• 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.

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-15
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09
• Primary Completion: 2023-09-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

Allergo Clinic Medical Center; 🇰🇿 Almaty, Kazakhstan

LLP LOR-Center Ai-Medicus; 🇰🇿 Almaty, Kazakhstan