An open-label, 28-day multiple dose pilot study to evaluate the effects on lung oxidative stress, safety and pharmacokinetics of TA-270 in patients with chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic obstructive pulmonary disease. ( COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2009-009096-35-GB
- Lead Sponsor
- Activus Pharma Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
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 < 70% and 30% = FEV1 < 80% predicted normal
value at Visit 1 (screening). This criterion must be demonstrated after a minimum
washout period (see exclusion criterion 18; i.e., 6 hours for inhaled short-acting
ß2-agonists (SABAs), 24 hours for long-acting ß2-agonists (LABAs), 8 hours for
short-acting anticholinergics including the fixed combinations with SABAs, 48 hours
for long-acting anticholinergics). The post-bronchodilator FEV1 will be measured
within 30 minutes after inhalation of SABA (salbutamol, 400 µg) and should not
increase by more than 400 mL as compared to the pre-bronchodilator FEV1.
3. Patients who are negative for hepatitis B surface antigen (HbsAg), hepatitis C
antibody and human immunodeficiency virus (HIV) I and II tests at screening.
4. Patients who are negative for drugs of abuse and alcohol tests at screening and
admission.
5. Patients who are able and willing to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method