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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01918293
Other study ID # SMART-ASTHMA (ADULT)
Secondary ID
Status Completed
Phase N/A
First received August 6, 2013
Last updated November 26, 2013
Start date September 2012
Est. completion date October 2013

Study information

Verified date November 2013
Source Inje University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- using smartphone

- alleged bronchial asthma over 3months & positive of bronchodilator response test or bronchial provocation test

Exclusion Criteria:

- COPD

- active pulmonary TUBERCULOSIS

- Acute exacerbation within 4weeks

- severe psychological disorder

- severe systemic disease; severe LC, ESRD ...

- MALIGNANCY

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
SMART ARM
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.

Locations

Country Name City State
Korea, Republic of Haeundae Paik Hospital Busan

Sponsors (1)

Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary FEV1 (Forced expiratory volume in 1 second ) and FVC (Forced vital capacity) Using spirometer to check the variation of FEV1,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 1 time a month No
Secondary Acute exacerbation of bronchial asthma Using medical record and questionaire of acute exacerbation,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 1 time a week No
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