跳至主要内容
临床试验/CTRI/2025/04/083804
CTRI/2025/04/083804尚未招募2/3 期

A Prospective Randomized Comparative study - To Asses the Effect and Safety of single daily dose of Fluticasone nasal spray against alternate day regimen in allergic rhinitis.

NA1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
NA
入组人数
80
试验地点
1
主要终点
Comparison between daily and alternate day regimen of fluticasone intranasal spray for allergic rhinitis.

研究概览

简要总结

NEED FOR STUDY:

o   Allergic rhinitis poses a considerable health concern, with prevalence estimates ranging between 15% to 20%. It affects a significant portion of the population across all age groups, including infants. Over the last four decades, there has been a notice able rise in the incidence of allergic rhinitis, attributed to factors such as industrialization and urbanization, leading to increased exposure to allergens. Additionally, pollution, irritants, lifestyle changes, dietary alterations reducing protective nutrients, decreased infection rates resulting in diminished Th1-type immune response, and stress contribute to this trend. (1)

 o   AR and MR are overlapping conditions that until recently have been classified as AR. It is becoming clearer that these conditions may behave differently with respect to clinical presentation, comorbidities, and response to treatment. There is ample evidence in the medical literature that shows a synergistic interaction between specific Ig E-mediated responses and air pollutants such as diesel exhaust particulate and ozone.26 –29 Further investigation is required to determine whether MR represents a continuum from AR that develops over time as a result of an enhanced immunologic response secondary to continued exposure to chemicals and/or particulate matter in the home or work environment or merely represents the development of NAR independently of the patient’s atopic status. Regardless, it is important for the clinician not to trivialize the distinction between these two CR conditions because it is clear that the clinical management of MR can be more challenging, leading to increased morbidity and health care costs and decreased quality of life. (2)

o   The findings of this study suggest that the prevalence of self-reported allergic rhinitis (AR) varies significantly across different cities in Mainland China.(3)

o   The reported prevalence rates ranged from less than 10% to more than 20% among participants surveyed in 11 cities. Additionally, the study identified that 26% of individuals self-reporting AR were categorized as experiencing persistent allergic rhinitis. These results highlight the importance of understanding regional differences in AR prevalence and the substantial proportion of individuals experiencing persistent symptoms, which could have implications for healthcare planning and resource allocation in China.Top of Form(4)

o   This study aims to know the effect and safety of daily versus alternate day regimen of fluticasone nasal spray to maximize efficacy, minimize potential systemic side effects, and improve patient adherence.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of both genders belonging to age group 6-60 years having clinical diagnosis on the basis of history and examination of allergic rhinitis symptoms.
  • Both seasonal and perennial allergic rhinitis .

排除标准

  • Patients who have undergone nasal surgery and immunotherapy for the purpose of treating AR.
  • Patients with nasal diseases, like nasal polyp, ear deviated nasal septum, infectious diseases like acute rhinitis, chronic rhinitis, congestive sinusitis, atrophic rhinitis, chronic rhinosinusitis flu associated rhinitis, membrane perforations.
  • 3.Patients with diabetes mellitus, asthma, hypertension and women who wanted to become pregnant or pregnant women or breast feeding women.
  • Patients with psychaitric illness.
  • Patients aged below the 6 years.
  • Patients aged above the 60 years.

结局指标

主要结局

Comparison between daily and alternate day regimen of fluticasone intranasal spray for allergic rhinitis.

时间窗: Daily and alternate day regimen of fluticasone intranasal spray for allergic rhinitis in baseline 8 weeks and 12 weeks

次要结局

  • Comparison of symptom relief in both therapy regimens.(Daily & alternate day symptom relief in both therapy regimens in baseline 8 weeks 12 weeks)

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Dr Nikhat Anjum

Adichunchanagiri Institute of Medical Sciences

研究点 (1)

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