self controlled clinical study for the effect of medicines in individual COPD patients.

12-week, open label, self controlled, clinical trial followed by 36-week observational study for the effect and adverse event of bronchodilators or anti-inflammatory drugs in individual patients with stable COPD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001092

Enrollment

112

Registered

2014-04-28

Start date

2014-05-08

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 : In this study, we will perform a 12-week, open label, self controlled, clinical trial followed by 36-week observational study for the effect and adverse event of bronchodilators or anti-inflamm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are diagnosed with COPD - Exertional dyspnea lasts for over a year - Smokers or ex-smokers with a history of smoking over 10 pack years. - Out-patients over 45 years of age. - Post-Bronchodilator FEV1/FVC <0.7 Wash-out period before enrollment - Patients of GOLD 1/2 can enroll with stopping LAMA and LABA over 4 weeks - Patients of GOLD 3/4 can enroll with stopping ICS and PDE4I over 4 weeks. - GOLD 3/4<Post BDR Fev1 % predicted 50=GOLD1/2

Exclusion criteria

Exclusion criteria: -Physician-diagnosed asthma -bronchiectasis -Tuberculosis destroyed lung -bituminosis -patient whose life expectancy is no more than two years are excluded from the study

Design outcomes

Primary

Measure	Time frame
Forced expiratory volume in 1 second	—

Secondary

Measure	Time frame
dyspnea score;cough/sputum;inflammatory biomarker	—

Countries

Korea, Republic of

Contacts

Public ContactYeon-Mok Oh

Asan Medical Center

Outcome results