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.
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- NA
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Comparison between daily and alternate day regimen of fluticasone intranasal spray for allergic rhinitis.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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 .
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Comparison between daily and alternate day regimen of fluticasone intranasal spray for allergic rhinitis.
Time Frame: Daily and alternate day regimen of fluticasone intranasal spray for allergic rhinitis in baseline 8 weeks and 12 weeks
Secondary Outcomes
- Comparison of symptom relief in both therapy regimens.(Daily & alternate day symptom relief in both therapy regimens in baseline 8 weeks 12 weeks)
Investigators
Dr Nikhat Anjum
Adichunchanagiri Institute of Medical Sciences