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临床试验/NCT07415278
NCT07415278进行中(未招募)4 期

INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION AS FIRST-LINE THERAPY IN ALLERGIC RHINITIS: A PROSPECTIVE COMPARATIVE STUDY

Pamukkale University1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
61
试验地点
1
主要终点
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score

研究概览

简要总结

This prospective comparative study was conducted to evaluate the clinical efficacy, onset of action, and side-effect profiles of intranasal fluticasone propionate (FP) monotherapy and a fluticasone propionate-azelastine (MP-AzeFlu) combination in adult patients with moderate-to-severe allergic rhinitis. Patients with positive skin prick test results were randomly assigned to receive either FP monotherapy or MP-AzeFlu combination therapy. Symptom severity and quality of life were assessed at baseline, day 7, month 1, and month 2 using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a visual analog scale (VAS). The primary objective was to compare changes in quality-of-life scores between treatment groups. Secondary outcomes included onset of symptom relief and treatment-related sensory side effects.

详细描述

Allergic rhinitis (AR) is a chronic inflammatory condition of the nasal mucosa that significantly affects patients' quality of life, sleep, and daily functioning. Intranasal corticosteroids are recommended as first-line therapy for moderate-to-severe AR; however, some patients experience delayed symptom relief or insufficient control. Combination therapy with an intranasal antihistamine and corticosteroid may provide faster and more effective symptom control, but comparative data on onset of action, quality-of-life outcomes, and side-effect profiles are limited.

This prospective, randomized, comparative clinical study was conducted at a tertiary care otorhinolaryngology clinic. Adult patients presenting with symptoms of allergic rhinitis and positive skin prick test results were screened. Patients with moderate-to-severe symptoms, defined by a Score for Allergic Rhinitis (SFAR) of 7 or higher, were included. Eligible participants were randomly assigned to one of two treatment groups: intranasal fluticasone propionate (FP) monotherapy or a fixed-dose combination of fluticasone propionate and azelastine hydrochloride (MP-AzeFlu). Treatments were administered according to the recommended dosing schedules.

Patients were evaluated at baseline and at day 7, month 1, and month 2 after treatment initiation. Clinical efficacy and quality of life were assessed using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a visual analog scale (VAS). The onset of action was defined as the first day on which patients reported noticeable symptom improvement. Adverse effects, particularly taste and smell disturbances, were also evaluated using VAS scores. The primary objective was to compare changes in quality-of-life scores between the two treatment groups, while secondary objectives included onset of symptom relief and the assessment of treatment-related side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

This was an open-label study. Both participants and investigators were aware of the assigned treatments, and no blinding was applied.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and older
  • Clinical symptoms consistent with allergic rhinitis
  • Positive skin prick test results
  • Moderate-to-severe allergic rhinitis defined as a Score for Allergic Rhinitis (SFAR) of 7 or higher
  • Willingness to participate and provide informed consent

排除标准

  • Patients under 18 years of age
  • Patients with atopic diseases (e.g., atopic dermatitis) or asthma, other than allergic rhinitis
  • Those with a recent respiratory tract infection, nasal polyps, or septal deviation
  • Patients who had previously undergone sinonasal surgical treatment
  • Individuals who use tobacco, alcohol, or illicit drugs
  • Those who have used the following medications:
  • Antihistamines (within the last week) Nasal or oral decongestants (within the last week) Topical corticosteroids (within the last 2 weeks) Membrane stabilizers (within the last 2 weeks) Leukotriene antagonists (within the last 2 weeks) Systemic corticosteroids (past 4 weeks) Immunotherapy (within the past 5 years)
  • Patients with allergic rhinitis symptom score <7

研究组 & 干预措施

Fluticasone Propionate Monotherapy

Experimental

Drug: Fluticasone propionate nasal spray

干预措施: Fluticasone propionate nasal spray (Drug)

Fluticasone-Azelastine Combination

Experimental

Drug: Fluticasone propionate-azelastine nasal spray

干预措施: Fluticasone propionate-azelastine nasal spray (Drug)

结局指标

主要结局

Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score

时间窗: Baseline to Month 2

Change in the total score of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) from baseline to 2 months after treatment initiation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erdem Mengi

Associate Professor

Pamukkale University

研究点 (1)

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