None listed
Conditions
Interventions
Drug : 400mg 1 tablet a day for 5 days, Placebo 1 tablet a day for 2 days, PO
400mg 1 tablet a day for 7 days, PO
Sponsors
Dong Hwa Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult male or female same or older than age of 40 - Severity of acute exacerbation of COPD must suit oral administration treatment - Diagnosed as COPD before receiving written informed consent and outcome measure of spirometry testing confirmed as FEV1/FVC < 0.7 - Subject showing following signs and symptoms: (i)Purulent Sputum or Sputum level is increased; (ii)Difficulty in breathing is increased - Female subjects who might be pregnant must do pregnancy test and results should be negative before randomization is done. She must receive written informed consent form (NOTE: Subject who has used single hormone contraception for pregnancy control or has not been more than 1 year after Tubul ligation and menopause are excluded from the study) - Subject who can agree and sign written informed consent form approved by IRB before participating in study and follow study requirements
Exclusion criteria
Exclusion criteria: - Subject who administered excess daily dose of antimicrobial/antibiotics in past 72 hours before receiving written consent - Diagnosed to have pneumonia by taking chest X-ray in past 48 hours before receiving written consent - Diagnosed to have infectious diseases or such diseases results in complications before receiving written consent (NOTE: Septic shock, Bronchiectasis, Lung abscess, Pneumonia, Active tuberculosis, Pulmonary malignancy, Cystic fibrosis, Empyema, Asthma) - Have kidney or liver diseases who correspond following criteria: (i) CCr 3 x ULN; (iv) Total bilirubin > 2 x ULN; (v) ALP > 2 x ULN. - Organic gastrointestinal disorder having abnormal absorption problem condition in past 6 months before receiving written consent (NOTE: Active Crohn's disease, active ulcerative colitis) - Diagnosed to have neutropenia where absolute neutrophil count is 450 msec) - Complex infections or diseases that can effect study assessment or need long-term antibiotic treatment exceeding 7 days - Subject who has participated in Clinical trials or Bioequivalence test in past 30 days before receiving written consent - Clinically significant by observations considered as unsuitable based on medical judgement by investigators where current condition can effect quality of safety or data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Cure Rate in the clinical populations | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical cure Rate in the clinical population;Clinical cure Rate in the microbiological PP population;Safety assessment;Microbiological response rate in the microbiological PP population;Change in EXACT-PRO score for clinical populations;Change in CAT score for clinical populations | — |
Countries
Korea, Republic of
Contacts
Public ContactYeon-Mok Oh
Asan Medical Center
Outcome results
None listed