NCT01918293

Brief Summary

Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough, wheezing and severe life-threatening attack and lower quality of life. In addition, it make large amount of socioeconomic loss as about 3.7 billion US dollars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

August 6, 2013

Last Update Submit

November 26, 2013

Conditions

BRONCHIAL ASTHMA

Keywords

ASTHMASMARTPHONE APPLICATION

Outcome Measures

Primary Outcomes (1)

  • The efficacy of smartphone application for asthma control test (ACT)and quality of life

    Using ACT and ALQL score (QoL), we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group

    at least 2 times a week

Secondary Outcomes (2)

  • FEV1 (Forced expiratory volume in 1 second ) and FVC (Forced vital capacity)

    at least 1 time a month

  • Acute exacerbation of bronchial asthma

    at least 1 time a week

Study Arms (2)

SMART arm

EXPERIMENTAL

Using smartphone application for control of asthma

Device: SMART ARM

conventional arm

NO INTERVENTION

non-using smartphone application for control asthma

Interventions

SMART ARMDEVICE

The smartphone application for self-management of Asthma offers symptom diary, general information for asthma, the information of asthma drugs,the guideline for inhaler and the specific action plan according to daily symptom and FEV1.

Also known as: SMART-Asthma
SMART arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • using smartphone
  • alleged bronchial asthma over 3months \& positive of bronchodilator response test or bronchial provocation test

You may not qualify if:

  • COPD
  • active pulmonary TUBERCULOSIS
  • Acute exacerbation within 4weeks
  • severe psychological disorder
  • severe systemic disease; severe LC, ESRD ...
  • MALIGNANCY

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haeundae Paik Hospital

Busan, 612-896, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study principal investigator

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 7, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

KR(1)