NCT02556073

ICS/LABA Combination With Integrated Dose Counter and Smartphone APP to Improve Asthma Control

The Use of fluticasone Propionate/Salmeterol Inhaler With Integrated Dose Counter and Smartphone Self Management to Improve Airway Inflammation and Asthma Control

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Smartphone action	Smartphone applications (Apps) can provides a platform not only to share health information at the point-of-living, including health assessments, personalized health plans, but also to remind the patients' medication adherence regularly. With the application of modern smartphone-based asthma self management deserves further investigation to improve asthma control.
DRUG	usual care	fluticasone/salmeterol 125/25 ug/puff, 2 puff bid plus salmeterol as-needed

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-08-01
• Completion: 2016-12-01
• First posted: 2015-09-22
• Last updated: 2015-09-22

Locations

1 site across 1 country: Taiwan