Inducible Laryngeal Obstruction in Severe Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Prevalence of ILO in the participants
研究概览
简要总结
The first part will be a comparative cross-sectional study to identify the frequency of ILO and other comorbidites among participants with asthma compared to a group of reference subjects without asthma, matched for age- and gender and race.
The second part will be a longitudinally observational study study following participants for one year after the cross-sectional study. The Maat-scores ILO-symptoms and asthma-outcomes longitudinally will be evaluated, .
详细描述
Inducible laryngeal obstruction (ILO) is characterized by inappropriate closure of the structures of the larynx causing reduced airflow. The symptoms are breathing difficulties that resemble those seen in asthmatic patients, such as dyspnea, coughing and stridor. ILO may be diagnosed by the continuous laryngoscopy during exercise test (CLE-test), where the larynx is visualized live on video as the patient runs to exhaustion on a treadmill whilst having a laryngoscope placed through the nose.
The prevalence of ILO in asthmatic patients will be assesed by preforming a CLE-test twice in all participants at baseline and again after one year. Participant will be given visual feedback and instructed in breathing techniques. Others common comorbidities will be assessed by questionnaires and clinical interview. All patients with asthma will have a respiratory polygraph recording.
Changes in ILO-symptoms and asthma-symptoms and outcomes will be assessed after 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe asthma (GINA 5)
- •Patients with mild-moderate well-treated asthma (GINA step 1-4)
- •Agroup of age- and gender matched control subjects without asthma also aged 18-
- •The patients must have had a stable disease the last one month before performing the CLE-test
排除标准
- •No have underlying neurologic disease.
- •No known cancer in the lung-head-neck
- •No known vocal cord pathology.
- •No history of life-threatening asthma required hospitalization.
结局指标
主要结局
Prevalence of ILO in the participants
时间窗: One year
Continues during exercise(CLE)-test score at 2 or more at glottis or supraglottic level (Score range 0 minimum -3 maximum) 3 is full closure, 0 i open.
Changes in continues during exercise (CLE-)-test score
时间窗: One year
The absolute change from baseline CLE-score (Score range 0 minimum -3 maximum). 3 is full closure in larynx, 0 is open.
次要结局
- Changes in mini-Asthma quality of life (m-AQLQ)(One year)
- The prevalence of OSA in asthma patients with ILO.(One year)
- Changes in asthma-controll score (ACT)(One year)
- Number of asthma-exercabations(One year)