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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2023-12-15

Brief Summary

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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).

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Detailed Description

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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

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Allergic Rhinitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients taking Dospray = 63

Patients who were prescribed Dospray as part of routine medical practice

non-interventional study

Intervention Type OTHER

non-interventional study

Рatients on other alternative treatment = 63

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

non-interventional study

Intervention Type OTHER

non-interventional study

Interventions

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non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No