Pragmatic randomized controlled trial for stepping down of asthma controller treatment in patients controlled

Pragmatic randomized controlled trial for stepping down of asthma controller treatment in patients controlled with low dose inhaled corticosteroid (ICS) and long-acting beta2 agonist (LABA)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002103

Enrollment

231

Registered

2016-10-14

Start date

2016-08-26

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Assigned the well-controlled asthmatic patients for 6 months with low dose ICS+LABA (twice a day) to one of three groups A: low dose ICS+LABA twice a day B: ICS monotherapy C:ICS+LABA once a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: # 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

Exclusion criteria

Exclusion criteria: # 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

Design outcomes

Primary

Measure	Time frame
Mean ACT score change between 6-month and baseline	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactSo-Young Park

Asan Medical Center

raina821563@gmail.com+82-2-3010-0349

Outcome results