The Use of fluticasone Propionate/Salmeterol Inhaler With Integrated Dose Counter and Smartphone Self Management to Improve Airway Inflammation and Asthma Control
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Changes of airway inflammation profile
研究概览
简要总结
Poor adherence to asthma controller medication may link to poor asthma outcome. A metered dose device with built-in dose counter helps physicians to monitor drug compliance in asthma patients. Mobile-phone based self management opens a window for better asthma control. The present study aims to investigate the relationship between the adherence to controller medication of combined inhaled corticosteroid/long acting beta2-agonists, assessing by integrated dose counter, and the level of airway inflammation and asthma control. Moreover, the investigators also use a new asthma self-management Apps to enhance drug compliance. With the application of the new, easily available tools, the investigator expect to increase adherence rates, and hence, to reduce airway inflammation and improve the level of asthma control.
详细描述
The study will be conducted as a prospective, observational, open labeled, randomized trial in a single center (Taipei Veterans General Hospital). After screening, the enrolled patients will be randomized to either routine care or Smartphone self management group. In the routine care group, the patient will be treated as routine practice as a real-world setting. No additional intervention will be done. In the Smartphone self management group, an asthma self management Apps (My asthma App, GlaxoSmithKline, Chinese version, or Line), which provides multiple function, including health information (real-time weather condition, air pollution index) at the point-of-living, personalized health assessments (asthma control test, peak flow rate) and interactive action plans (green, yellow, and red light), and regular reminding for controller administration, will be downloaded to the participant's Smartphone. The participant will be educated to operate the Apps to improve asthma control. Participants in both groups will use identical controller (Sal/flu 2 inhalations twice daily plus as-needed rescue ventolin) and will be scheduled to follow up for 24 weeks.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic asthmatics free of controller medication for at least 3 months
- •Aged from 20 to 70 years
- •Life-long smoking index < 10 pack-years
排除标准
- •COPD, clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
- •A chest X-ray indicating diagnosis other than asthma that might interfere with the study.
- •Major disease abnormalities are uncontrolled on therapy.
- •Alcohol or medication abuse.
- •Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
- •Unable or unwilling to comply with all protocol
- •Unable to use Smartphone
研究组 & 干预措施
Usual care
"Usual care" means that intervention by fluticasone/salmeterol 125/25 2 puffs bid plus salbutamol as needed acts as asthma controller and patients will be scheduled to revisit clinics.
干预措施: usual care (Drug)
Usual care+Smartphone action
Intervention by fluticasone/salmeterol 125/25 2 puffs bid plus salbutamol as needed and Smartphone action, which provides the real-time health information of surroudings and actively remind the patients to use controller.
干预措施: Smartphone action (Other)
Usual care+Smartphone action
Intervention by fluticasone/salmeterol 125/25 2 puffs bid plus salbutamol as needed and Smartphone action, which provides the real-time health information of surroudings and actively remind the patients to use controller.
干预措施: usual care (Drug)
结局指标
主要结局
Changes of airway inflammation profile
时间窗: Changes of airway inflammation profile from baseline at 24 weeks
measurement including exhaled NO, cell counts and mediator in induced sputum before (baseline, wk0) and after treatment (wk 24)
次要结局
- changes of scores of asthma control questionnaire(Changes of scores of asthma control questionnaire from baseline at 24 weeks)
- Changes of lung function parameters(Changes of lung function parameters (FEV1, FVC) from baseline at 24 weeks)
- Numbers of rescue medication use(Total numbers of rescue medication use during 24-week period)