EVALUATION OF THE EFFECTIVENESS AND SAFETY OF DOSPRAY® NAZAL SPRAY IN

Status Recruiting

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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05896241
Study type	Observational [Patient Registry]
Source	LeKos LLP
Contact	Aigul Medeulova, MD
Phone	+7 701 421 77 65
Email	medeulova@bk.ru
Status	Recruiting
Phase
Start date	May 15, 2023
Completion date	December 15, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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 Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms