Clinical trial NCT05896241: EVALUATION OF THE EFFECTIVENESS AND SAFETY OF DOSPRAY® NAZAL SPRAY IN THE SYMPTOMATIC TREATMENT OF PERSISTENT ALLERGIC RHINITIS: A POST-REGISTRATION OBSERVATION STUDY
Official title: EVALUATION OF THE EFFECTIVENESS AND SAFETY OF DOSPRAY® NAZAL SPRAY IN THE SYMPTOMATIC TREATMENT OF PERSISTENT ALLERGIC RHINITIS: A POST-REGISTRATION OBSERVATION STUDY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Rhinitis
Lead sponsor: LeKos LLP
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons aged ≥18 to 65 years inclusive with a diagnosis of persistent allergic rhinitis who are under outpatient observation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS)
timeFrame: [Time: 7 days]
Secondary outcomes:
measure: Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS)
timeFrame: [Time: 7 days]
measure: Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS)
timeFrame: [Time: 7 days]
measure: Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms.
timeFrame: [Time: 7 days]
measure: Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores
timeFrame: [Time: 7 days]
measure: Adverse reactions - Number of yellow cards.
timeFrame: [Time: 7 days]
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Allergo Clinic Medical Center
city: Almaty
country: Kazakhstan
facility: LLP LOR-Center Ai-Medicus
Study officials:
References: