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

Last updated: May 31, 2023
Sponsor: LeKos LLP
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nasal Obstruction

Allergies & Asthma

Common Cold

Treatment

non-interventional study

Clinical Study ID

NCT05896241
№ LK-01-D
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 partof routine medical practice outside the study.
  • Voluntary desire to provide informed consent to participate in the study.

Exclusion

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 inthe 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 septumrequiring surgical correction;
  • Infectious diseases of the upper respiratory tract within 14 days before enrollment inthe study;
  • Patients prone to nosebleeds, having glaucoma, convulsive syndrome or otherneuropsychiatric pathologies.

Study Design

Total Participants: 126
Treatment Group(s): 1
Primary Treatment: non-interventional study
Phase:
Study Start date:
May 15, 2023
Estimated Completion Date:
December 15, 2023

Study 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.

Connect with a study center

  • Allergo Clinic Medical Center

    Almaty, 050043
    Kazakhstan

    Active - Recruiting

  • LLP LOR-Center Ai-Medicus

    Almaty,
    Kazakhstan

    Active - Recruiting

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