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临床试验/NCT05603494
NCT05603494招募中不适用

The Use of Home Spirometry in the Monitoring of Patients With Acute Exacerbation of Asthma

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
To compare between changes in asthma symptoms and pulmonary function by home spirometry

研究概览

简要总结

After outpatient clinic visit, asthmatic patients with worsening of symptoms (including dyspnea, wheezing, chest tightness, cough, activity limitation, awaken in the midnight due to discomfort) and are diagnosed of acute exacerbation by physician, will be recruited. The patients are asked to record symptoms using asthma symptom diary (ASD) with home spirometry simultaneously for 14 days.

Visit 1 (day 1)

All patients will be evaluated the following:

  1. Record the patients' demographics (age, gender, race), baseline characteristics, comorbidities, health care resources use (visits, lab tests, hospitalization and cost), pharmacological and non-pharmacological treatments
  2. Blood sampling for eosinophils, eosinophil cationic protein (ECP) and immunoglobulin E (IgE) as clinically indicated (if no data available within one year for the last two)
  3. The study assistant will introduce to the patient how to manipulate the home spirometry and its app, and to record the daily asthma symptoms by using the ASD on the mobile phone.

Visit 2 (day 15) All patients will be arranged outpatient clinic follow up 2 weeks later from the first visit. The outpatient clinic physician will check the home spirometry report and ASD symptom score in the past 2 weeks, and have a well explanation of these results.

Statistical analysis The usage of digital function including input ASD, and the lung function from portable spirometer in study arm will be demonstrated by descriptive statistics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20 to 75 years old asthmatic patients under regular treatment for at least 3 months.
  • Patients in asthma acute exacerbation (symptoms onset within 1 week) and received oral corticosteroid for more than 3 days.

排除标准

  • Refuse to provide inform consent.
  • Patients with chronic obstructive pulmonary disease.
  • Patients who receive more than 20mg prednisone or equivalent dose per day.
  • Patients who are incapable of using smart phone.

结局指标

主要结局

To compare between changes in asthma symptoms and pulmonary function by home spirometry

时间窗: 2 weeks

To compare between changes in asthma symptoms by asthma symptom diary (scoring in points) and changes in forced expiratory volume in 1 second (FEV1, in liters) in patients with acute exacerbation of asthma. Asthma symptom diary (ASD) consist of daytime and nighttime score will be recorded everyday over the 14-day study period.

次要结局

  • To compare the changes in daily asthma rescue medication use and pulmonary function by home spirometry(2 weeks)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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