ACTRN12605000473662已完成3 期
A randomised, double-blind, placebo controlled trial of the effect versus placebo of twice daily doses of mannitol (80mg) for one week on nasal mucociliary clearance in healthy adults and adults with allergic rhinitis or chronic sinusitis.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •All subjects must: be able to give written, informed consent; be willing, able and likely to complete the study including compliance with study procedures and restrictions; be able to read, comprehend and record information in English; be between 18 and 70 years of age at first visit; be non-smokers. Only females >55 years of age who have not had a menstrual period in the last 12 months or females <55 years of age who have not had a menstrual period in the past 12 months and who have had their post-menopausal condition confirmed by laboratory blood test, will be eligible to participate.
- •In addition, all subjects must withhold the following medications prior to and for the duration of the study: intranasal steroids, 2 weeks; oral or intranasal antihistamines, 48 h; intranasal decongestants, 24 h.Healthy subjects: Must have no upper or lower respiratory diseases or disorders; no current symptoms of allergic rhinitis or chronic sinusitis; no history of allergic rhinitis or chronic sinusitis; no severe physical obstruction of the nose (i.e. deviated septum or nasal polyps).Persistent allergic rhinitis subjects: Must have a positive skin prick test response to a perennially-occurring allergen (animal dander, house dust mite, cockroach, mould) within the last 12 months; have nasal symptoms that are present for more than 4 days a week and for more than 4 weeks per year (current definition of persistent allergic rhinitis)[15].Chronic rhinosinusitis: Must have had symptoms continuously present for >12 weeks; must present with 2 or more major factors or 1 major and at least 2 minor factors from the following lists; Major: facial pain/pressure nasal blockage, nasal discharge/purulence/ discoloured postnasal drainage, hyposmia/anosmia; purulence in nasal cavity on examination. Minor: headache, fever, halitosis, fatigue, dental pain, cough, ear pain/pressure/fullness[16]. An abnormal CT scan will be required to confirm the diagnosis. Previous surgery does not exclude the subject so long as the latest CT scan is abnormal.
排除标准
- •Current asthmatics will be excluded from the study and all subjects will have a baseline FEV1 which is >70% predicted.
研究者
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