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

• Sponsor: LeKos LLP (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05896241
• Collaborator: (none)
• Enrollment: 126
• Locations: 2
• Anticipated Duration (Months): 7
• Patients Per Site: 63
• Patients Per Site Per Month: 9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Other: non-interventional study

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 126 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Actual Study Start Date: May 15, 2023
• Anticipated Primary Completion Date: Sep 15, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients taking Dospray = 63 Patients who were prescribed Dospray as part of routine medical practice	Other: non-interventional study; 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; non-interventional study

Outcome Measures

Primary Outcome Measures

1. Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) [[Time: 7 days]]

Secondary Outcome Measures

1. Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS) [[Time: 7 days]]

2. Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS) [[Time: 7 days]]

3. Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms. [[Time: 7 days]]

4. Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores [[Time: 7 days]]

5. Adverse reactions - Number of yellow cards. [[Time: 7 days]]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allergo Clinic Medical Center	Almaty		Kazakhstan	050043
2	LLP LOR-Center Ai-Medicus	Almaty		Kazakhstan

Sponsors and Collaborators

• LeKos LLP

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LeKos LLP
• ClinicalTrials.gov Identifier: NCT05896241
• Other Study ID Numbers: № LK-01-D
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic

Study Results

No Results Posted as of Jun 9, 2023