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

September 20, 2015 updated by: Taipei Veterans General Hospital, Taiwan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 886
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: usual care
fluticasone/salmeterol 125/25 ug/puff, 2 puff bid plus salmeterol as-needed
Other Names:
  • asthma controller
Experimental: 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.
Drug: usual care
fluticasone/salmeterol 125/25 ug/puff, 2 puff bid plus salmeterol as-needed
Other Names:
  • asthma controller
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.
Other Names:
  • asthma controller+Smartphone self-management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of airway inflammation profile
Time Frame: Changes of airway inflammation profile from baseline at 24 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of scores of asthma control questionnaire
Time Frame: Changes of scores of asthma control questionnaire from baseline at 24 weeks
scores of questionnaire of asthma control test (ACT)
Changes of scores of asthma control questionnaire from baseline at 24 weeks
Changes of lung function parameters
Time Frame: Changes of lung function parameters (FEV1, FVC) from baseline at 24 weeks
Changes of lung function parameters (FEV1, FVC) from baseline at 24 weeks
Numbers of rescue medication use
Time Frame: Total numbers of rescue medication use during 24-week period
Total numbers of rescue medication use during 24-week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Kang-Cheng Su Su, Md. MS, Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

September 20, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 20, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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