Clinical trial NCT02556073: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: asthma control
adherence
asthma self management plan
airway inflammation
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2015-09-22
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of airway inflammation profile
timeFrame: Changes of airway inflammation profile from baseline at 24 weeks
Secondary outcomes:
measure: changes of scores of asthma control questionnaire
timeFrame: Changes of scores of asthma control questionnaire from baseline at 24 weeks
measure: Changes of lung function parameters
timeFrame: Changes of lung function parameters (FEV1, FVC) from baseline at 24 weeks
measure: Numbers of rescue medication use
timeFrame: Total numbers of rescue medication use during 24-week period
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Kang-Cheng Su Su, Md. MS
role: PRINCIPAL_INVESTIGATOR
References: