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临床试验/NCT01562093
NCT01562093终止不适用

Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
14
试验地点
1
主要终点
forced expiratory volume

研究概览

简要总结

In this study we will investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.

详细描述

Although up to 95% of asthma patients suffer from blocked nose, the majority of these patients do not undergo systematic assessment and treatment for nasal blockage. This is unfortunate, as optimal diagnosis and treatment of nasal blockage in asthmatics can reduce asthma morbidity and use of anti-asthmatic medication.

The "Unified Airways" concept considers the upper and lower airways as one unified airway. In recent years there has been increasing awareness about the relationship between inflammation in the upper and lower airways, with disease in the upper airways affecting the lungs through neurological, immunological and mechanical mechanisms, resulting in asthmatic symptoms.

Conditioning and filtration of the inspired air are important functions of the nose, and oral breathing results in inhalation of poorly conditioned and filtered air in to an already inflamed lower airway. Together will these mechanisms lead to a worsening of the asthmatic disease.

The aim of this study is to investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms. The primary outcome variable is improvement in asthma symptomatology. The secondary outcome variables are improvement in nasal blockage.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • asthma (according to British Thoracic Society guideline)
  • >18 years

排除标准

  • pregnancy
  • systemic disease with nasal manifestations
  • cancer of the nose
  • currently receiving cancer therapy
  • previous nose surgery

研究组 & 干预措施

local nasal steroids

Experimental

干预措施: corticosteroid nasal spray (Drug)

placebo

Placebo Comparator

干预措施: placebo nasal spray (Drug)

结局指标

主要结局

forced expiratory volume

时间窗: up to 12 weeks

spirometry, methacholine and mannitol

次要结局

  • nasal and exhaled NO(up to 12 weeks)
  • improvement in nasal blockage(up to 12 weeks)
  • wheeze(up to 12 weeks)
  • subjective improvement in asthma symptomatology(up to 12 weeks)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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