NCT02556073

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

2 years

First QC Date

November 25, 2014

Last Update Submit

September 20, 2015

Conditions

Asthma

Keywords

asthma controladherenceasthma self management planairway inflammation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • changes of scores of asthma control questionnaire

    Changes of scores of asthma control questionnaire from baseline at 24 weeks

  • Changes of lung function parameters

    Changes of lung function parameters (FEV1, FVC) from baseline at 24 weeks

  • Numbers of rescue medication use

    Total numbers of rescue medication use during 24-week period

Study Arms (2)

Usual care

ACTIVE COMPARATOR

"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

Usual care+Smartphone action

EXPERIMENTAL

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.

Other: Smartphone actionDrug: usual care

Interventions

Smartphone actionOTHER

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.

Also known as: asthma controller+Smartphone self-management
Usual care+Smartphone action
usual careDRUG

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

Also known as: asthma controller
Usual careUsual care+Smartphone action

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic asthmatics free of controller medication for at least 3 months
  • Aged from 20 to 70 years
  • Life-long smoking index \< 10 pack-years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan, 886, Taiwan

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Kang-Cheng Su Su, Md. MS

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

September 22, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

TW(1)