Pragmatic randomized controlled trial for stepping down of asthma controller treatment in patients controlled
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0002103
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 231
# meet all of the following criteria
1) At least 19 years of age with asthma - any of following
- positive response bronchodilator : increase in FEV1 by 12% and 200 mL from baseline after inhaled bronchodilator (short acting beta agonist (SABA) 2-4 puff)
- positive methacholine test
- after asthma treatment, increase in FEV1 more than 15%
2) Asthma control test (ACT) score is more than 20 and predictive FEV1 is more than70% (>=70)
3) No history of acute exacerbation during past 6 months
# any of following
1) Patients who are received other asthma medication (leukotriene receptor antagonist (LTRA), anticholinergics. methylxanthine, systemic steroid, omalizumab etc)
2) Patients receiving immunosuppressant therapy (methotrexate, cyclosporine)
3) chronic obstructive pulmonary disease (COPD), bronchiectasis, TB destroyed lung, interstitial lung disease (ILD)
4) lower respiratory tract infection history during the recent one month (such as pneumonia)
5) pregnancy and breast feeding
6) other patients judged to be inappropriate by clinician
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean ACT score change between 6-month and baseline
- Secondary Outcome Measures
Name Time Method change of lung function (FEV1);K-AQLQ (Asthma Quality of Life Questionnaire);time to fist loss of control or exacerbation ;Symptom free days (%);Change of fractionated exhaled nitrogen oxide (FENO);Use of Rescue medication ;Safety (mediation-related adverse event)