ICS/LABA Combination With Integrated Dose Counter and Smartphone APP to Improve Asthma Control
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Smartphone action
usual care
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma control, adherence, asthma self management plan, airway inflammation
Eligibility Criteria
Inclusion Criteria:
- Symptomatic asthmatics free of controller medication for at least 3 months
- Aged from 20 to 70 years
- Life-long smoking index < 10 pack-years
Exclusion Criteria:
- 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
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual care
Usual care+Smartphone action
Arm Description
"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.
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.
Outcomes
Primary Outcome Measures
Changes of airway inflammation profile
measurement including exhaled NO, cell counts and mediator in induced sputum before (baseline, wk0) and after treatment (wk 24)
Secondary Outcome Measures
changes of scores of asthma control questionnaire
scores of questionnaire of asthma control test (ACT)
Changes of lung function parameters
Numbers of rescue medication use
Full Information
NCT ID
NCT02556073
First Posted
November 25, 2014
Last Updated
September 20, 2015
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02556073
Brief Title
ICS/LABA Combination With Integrated Dose Counter and Smartphone APP to Improve Asthma Control
Official Title
The Use of fluticasone Propionate/Salmeterol Inhaler With Integrated Dose Counter and Smartphone Self Management to Improve Airway Inflammation and Asthma Control
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma control, adherence, asthma self management plan, airway inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
"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.
Arm Title
Usual care+Smartphone action
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Smartphone action
Other Intervention Name(s)
asthma controller+Smartphone self-management
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
usual care
Other Intervention Name(s)
asthma controller
Intervention Description
fluticasone/salmeterol 125/25 ug/puff, 2 puff bid plus salmeterol as-needed
Primary Outcome Measure Information:
Title
Changes of airway inflammation profile
Description
measurement including exhaled NO, cell counts and mediator in induced sputum before (baseline, wk0) and after treatment (wk 24)
Time Frame
Changes of airway inflammation profile from baseline at 24 weeks
Secondary Outcome Measure Information:
Title
changes of scores of asthma control questionnaire
Description
scores of questionnaire of asthma control test (ACT)
Time Frame
Changes of scores of asthma control questionnaire from baseline at 24 weeks
Title
Changes of lung function parameters
Time Frame
Changes of lung function parameters (FEV1, FVC) from baseline at 24 weeks
Title
Numbers of rescue medication use
Time Frame
Total numbers of rescue medication use during 24-week period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic asthmatics free of controller medication for at least 3 months
Aged from 20 to 70 years
Life-long smoking index < 10 pack-years
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang-Cheng Su Su, Md. MS
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
886
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
ICS/LABA Combination With Integrated Dose Counter and Smartphone APP to Improve Asthma Control
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