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

NCT05896241 | Unknown

• 1 other identifier: № LK-01-D
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 2

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. 1.Patients taking Dospray = 63
2. 2.Patients on other alternative treatment = 63 Duration of Patient Participation - 7-10 days (duration of treatment for an individual patient).

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS)

  [Time: 7 days]

Secondary Outcomes (5)

• 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]

• 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]

• Adverse reactions - Number of yellow cards.

  [Time: 7 days]

Study Arms (2)

Patients taking Dospray = 63

Patients who were prescribed Dospray as part of routine medical practice

Other: non-interventional study

Рatients on other alternative treatment = 63

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

Other: non-interventional study

Interventions

non-interventional study OTHER

non-interventional study

Patients taking Dospray = 63; Рatients on other alternative treatment = 63

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Persons aged 18 to 65 years
• 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.

You may not qualify if:

• Objective symptoms suggestive of renal, hepatic, or heart failure;
• Pregnant and lactating women;
• 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.

Sponsors & Collaborators

• LeKos LLP: lead

Study Sites (2)

Allergo Clinic Medical Center

Almaty, 050043, Kazakhstan

RECRUITING

LLP LOR-Center Ai-Medicus

Almaty, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Aigul Medeulova, MD

CONTACT

+7 701 421 77 65; medeulova@bk.ru

Kanat Khazhidinov, MD

CONTACT

+77074138263; kanat_kh@mail.ru

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: May 15, 2023
• Primary Completion: September 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KA (2)