NCT05896241招募中不适用
EVALUATION OF THE EFFECTIVENESS AND SAFETY OF DOSPRAY® NAZAL SPRAY IN THE SYMPTOMATIC TREATMENT OF PERSISTENT ALLERGIC RHINITIS: A POST-REGISTRATION OBSERVATION STUDY
LeKos LLP2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS)
研究概览
简要总结
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:
- Patients taking Dospray = 63
- Patients on other alternative treatment = 63 Duration of Patient Participation - 7-10 days (duration of treatment for an individual patient).
详细描述
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:
- Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) [Time: 7 days]
- 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)
- 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 [Time: 7 days] Number of yellow cards.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons aged 18 to 65 years
- •Total TNSS score on the day of inclusion in the study equal to or greater than
- •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.
排除标准
- •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.
结局指标
主要结局
Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS)
时间窗: [Time: 7 days]
次要结局
- 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])
- Adverse reactions - Number of yellow cards.([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])
研究者
研究点 (2)
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