Chronic obstructive pulmonary disease. ( COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: 100 mg TA-270
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: TA-270
Other descriptive name: 4-hydroxy-1-methyl-3-octyloxy-7-sinapinoylamino-2(1H)-quinolinone
Concentration
Sponsors
Activus Pharma Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult males and females aged 40 to 75 years inclusive. 2. Co-operative outpatients with a clinical diagnosis of COPD according to the GOLD Guidelines (updated 2007), and who additionally meet the following criteria: a) Smoking history of at least 10 pack years. b) Post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who do not conform to the above inclusion criteria. 2. Patients who have been hospitalized for an exacerbation of COPD in the 6 weeks prior to Visit 1 (screening) or the run-in period (Visit 1 – Visit 2). 3. Patients who need long-term oxygen therapy (>16 h/day). 4. Patients with a history of asthma suspected by (but not limited to): a) Blood eosinophil count 0.4 x 109/L. b) Onset of symptoms prior to age 40 years. 5. Patients with concomitant pulmonary disease including lung cancer (irrespective of outcome), pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), bronchiectasis (congenital and acquired), diffuse panbronchiolitis, obliterative bronchiolitis, pneumoconiosis, interstitial lung disease, fibrosis, sarcoidosis or cystic fibrosis. 6. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (screening). Patients who develop a respiratory tract infection during the run-in period (Visit 1 – Visit 2) must discontinue from the trial, but may be permitted to re-enroll at a later date (at least 6 weeks after the start of the respiratory tract infection). 7. Patients with a history of heart failure or myocardial infarction within 3 months prior to Visit 1 (screening) or during the run-in period (Visit 1 – Visit 2). 8. Patients with a history of significant bleeding episode or coagulation disorder within 3 months prior to Visit 1 (screening) or during the run-in period (Visit 1 – Visit 2). 9. Patients with a known history of chronic alcoholics or drug abuse. 10. Patients who, in the judgment of the Investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertention, type-I or uncontrolled type-II diabetes, or any condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. 11. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable. 12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of female after conception and until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hCG) laboratory test. 13. Male and female patients who do not agree to use two effective methods of contraception (as defined in Section 7.2.3.2) for the duration of the study and for 3 months after the final dose of TA-270. 14. Patients with a history of clinically significant dug allergy to any of drugs with similar chemical structure to TA-270 or any components of the study drug. 15. Patients who have had treatment with other investigational drugs at the time of enrollment, or within 3 months or 5 half-lives prior to Visit 1 (screening), whichever is longer. 16. Patients who have had live attenuated vaccinations within 30 days prior to Visit 1 (screening) or during the run-in period (Visit 1 – Visit 2). Inactivated influenza vaccination, pneumococcal vaccination or any other inactivated vaccine is acceptable provided it is not administered within 48 h prior to Visits 1 or 2. 17. Patients who have had treatment with the following medications within a specified period prior to Visit 1. These medi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of TA-270 on predictive biomarkers of oxidative stress in exhaled breath condensate (EBC) such as 8-isoprostane and hydrogen peroxide (H2O2) and after 28 days treatment (Visit 4) as compared with baseline (Visit 2).;Secondary Objective: To evaluate the effects of TA-270 on exhaled 8-isoprostane and H2O2 after 14 days treatment (Visit 3) as compared with baseline (Visit 2). To evaluate the effects of TA-270 on biomarkers of oxidative stress (8-isoprostane) and neutrophils in induced sputum after 14 (Visit 3) and 28 days treatment (Visit 4) as compared with baseline (Visit 2). To evaluate the effects of TA-270 on leukotrienes B4 (LTB4) in EBC and induced sputum after 14 (Visit 3) and 28 days treatment (Visit 4) as compared to the baseline (Visit 2). To assess the safety and tolerability of multiple oral doses of TA-270 in patients with COPD (physical tests, laboratory tests, vital signs, ECG and adverse events).;Primary end point(s): To assess the effects of TA-270 on predictive biomarkers of oxidative stress in exhaled breath condensate (EBC) such as 8-isoprostane and hydrogen peroxide (H2O2) and after 28 days treatment (Visit 4) as compared with baseline (Visit 2). | — |
Countries
United Kingdom
Outcome results
None listed