Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial
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
- 否
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
干预措施: corticosteroid nasal spray (Drug)
placebo
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)
