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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02556073
• Other study ID #: 20140218
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 25, 2014
• Last updated: September 20, 2015
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 112
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Symptomatic asthmatics free of controller medication for at least 3 months

2. Aged from 20 to 70 years

3. Life-long smoking index < 10 pack-years

Exclusion Criteria:

1. COPD, clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.

2. A chest X-ray indicating diagnosis other than asthma that might interfere with the study.

3. Major disease abnormalities are uncontrolled on therapy.

4. Alcohol or medication abuse.

5. Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.

6. Unable or unwilling to comply with all protocol

7. Unable to use Smartphone

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of airway inflammation profile	measurement including exhaled NO, cell counts and mediator in induced sputum before (baseline, wk0) and after treatment (wk 24)	Changes of airway inflammation profile from baseline at 24 weeks	No
Secondary	changes of scores of asthma control questionnaire	scores of questionnaire of asthma control test (ACT)	Changes of scores of asthma control questionnaire from baseline at 24 weeks	No
Secondary	Changes of lung function parameters		Changes of lung function parameters (FEV1, FVC) from baseline at 24 weeks	No
Secondary	Numbers of rescue medication use		Total numbers of rescue medication use during 24-week period	No