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

NCT ID: NCT02556073

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-12-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: DRUG

fluticasone/salmeterol 125/25 ug/puff, 2 puff bid plus salmeterol as-needed

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.

Group Type: EXPERIMENTAL

Smartphone action

Intervention Type: OTHER

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.

usual care

Intervention Type: DRUG

fluticasone/salmeterol 125/25 ug/puff, 2 puff bid plus salmeterol as-needed

Interventions

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.

Intervention Type: OTHER

usual care

fluticasone/salmeterol 125/25 ug/puff, 2 puff bid plus salmeterol as-needed

Intervention Type: DRUG

Other Intervention Names

asthma controller+Smartphone self-management; asthma controller

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kang-Cheng Su Su, Md. MS

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

20140218

Identifier Type: -

Identifier Source: org_study_id