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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896241
• Other study ID #: ? LK-01-D
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2023
• Source: LeKos LLP
• Contact: Aigul Medeulova, MD
• Phone: +7 701 421 77 65
• Email: medeulova[@]bk.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• non-interventional study
non-interventional study

Locations

Country	Name	City	State
Kazakhstan	Allergo Clinic Medical Center	Almaty
Kazakhstan	LLP LOR-Center Ai-Medicus	Almaty

Sponsors (1)

Lead Sponsor	Collaborator
LeKos LLP

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS)		[Time: 7 days]
Secondary	Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS)		[Time: 7 days]
Secondary	Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS)		[Time: 7 days]
Secondary	Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms.		[Time: 7 days]
Secondary	Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores		[Time: 7 days]
Secondary	Adverse reactions - Number of yellow cards.		[Time: 7 days]