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

LeKos LLP

Status: Enrolling

Conditions: Allergic Rhinitis

Treatments: Other: non-interventional study

Study type: Observational

Funder types: Industry

Identifiers

NCT05896241

№ LK-01-D

Details and patient eligibility

About

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).

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

126 participants in 2 patient groups

Patients taking Dospray = 63

Description:

Patients who were prescribed Dospray as part of routine medical practice

Treatment:

Other: non-interventional study

Рatients on other alternative treatment = 63

Description:

Patients who have been prescribed other alternative treatment as part of routine medical practice

Treatment:

Other: non-interventional study