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临床试验/NCT01847131
NCT01847131已完成4 期

Effectiveness of Oxymetazoline Added on Intranasal Steroid in the Treatment of Allergic and Nonallergic Rhinitis With Persistent Nasal Obstruction

Mahidol University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction

研究概览

简要总结

Background Allergic rhinitis is a common health problem with a worldwide prevalence is 10-25%, and poses significant impact on the quality of life of the patients. In Thailand, the prevalence of allergic rhinitis in the general population is 13.5%, of which the frequency of allergic rhinitis increased from 23% to 38% in the children, and 61.9% in the graduate students. Despite intranasal steroid being the current first-line treatment of patients with allergic rhinitis, only 60% of patients achieve excellent control. Persistent nasal congestion is the major symptom which is difficult to control in these patients. Data are limited about efficacy and safety of the additional use of 0.05% intranasal oxymetazoline hydrochloride (OXY) for persistent nasal congestion that does not adequately respond to recommended doses of intranasal steroid (INS) and oral antihistamine(OAH).

Objective To determine the efficacy and safety of the additional use of OXY for persistent nasal congestion in allergic rhinitis or non-allergic rhinitis patients inadequately controlled by combination treatment with INS and OAH.

Methods The investigators performed a 6-week, randomized, double blind, placebo controlled, clinical trial in 50 patients with allergic rhinitis or non-allergic rhinitis whom inadequately controlled by combination treatment with INS and oral antihistamine (OAH). After an initial screening, qualified individuals were randomized into 2 groups including the treatment group and the control group. The treatment group received the INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) plus OXY (2 puffs in each nostril twice daily) The control group received INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) plus placebo (2 puffs in each nostril twice daily).

详细描述

All participants will continue medications for 4 weeks, then stop using interventional medication and still take INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) for 2 more weeks. Then, all participants will come for the last visit to see whether rebound nasal symptoms occur. Participants will be asked to record nasal symptom diary card, and nasal peak inspiratory flow. Rhinoconjunctivitis Quality of life Questionnaire (Rcq) will be recorded during visit.

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
Double (Participant, Investigator)

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

  • Patient 18 years of age or greater
  • Diagnosis with allergic or nonallergic rhinitis with persistent nasal obstruction
  • Being treated with intranasal steroid and oral antihistamine

排除标准

  • Underlying disease of hypertension
  • Use oral or nasal decongestant 7 days prior to entering the study
  • Nasal polyp or significant deviated nasal septum
  • Respiratory tract infection 14 days prior to entering the study

研究组 & 干预措施

oxymetazoline

Active Comparator

0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily

干预措施: oxymetazoline (Drug)

placebo

Placebo Comparator

placebo nasal spray 2 sprays in each nostril twice daily

干预措施: Placebo nasal spray (Drug)

结局指标

主要结局

Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction

时间窗: 6 weeks

Primary outcome measure is the nasal congestion score measuring by visual analog scale (VAS) ranging from 1-10 (0 = no symptom and 10 = the most severe symptom) compared between treatment group and controlled group.

次要结局

  • The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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