EUCTR2008-000301-11-DE进行中（未招募）不适用
A 12-week treatment, multi-center, randomized, double-blind, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 µg o.d.) in patients with chronic obstructive pulmonary disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be included in the study the patient must satisfy all inclusion / exclusion criteria at Visit 1, and prior to randomization at Visit 3 unless specified otherwise.
- •1. Male and female adults aged =40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
- •2. Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2005, Appendix 5) and including:
- •a) Smoking history of at least 20 pack years
- •b) Post-bronchodilator FEV1 <80% and =30% of the predicted normal value.
- •c) Post-bronchodilator FEV1/FVC < 70%
- •(Post refers to within 30 min of inhalation of 400 µg (4x100µg) of salbutamol, equivalent to 4 x 90 µg albuterol delivered at the mouthpiece, at Visit 1).
- •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
排除标准
- •1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (>5 mIU/mL)
- •2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or are using one or more of the following acceptable methods of contraception.
- •3. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
- •4. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD exacerbation). This is typically patients requiring oxygen therapy >15 h per day delivered by home oxygen cylinder or concentrator
- •5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection between Visit 1 and Visit 3 must discontinue from the trial, but may (subject to agreement from the Novartis Medical Monitor) be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection)
- •6. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis
- •7. Patients with a history (up to and including Visit 1) of asthma indicated by (but not limited to):
- •a) blood eosinophil count > 400/mm3 and
- •b) onset of respiratory symptoms prior to age 40 years
- •8. Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c > 8.0 % of total Hb measured at Visit 1
- •9. Patients who, in the judgment of the investigator or the responsible Novartis personnel, 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 hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
- •10. Any patient with lung cancer or a history of lung cancer
- •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. Patients with a history of cancer (excluding lung cancer) and 5 years or more disease-free survival time may only be included in the study by agreement with Novartis Headquarters personnel on a case-by-case basis
- •12. Patients with a history (or family history) of long QT syndrome or whose QTc interval (Bazett’s) measured at Visit 1 or Visit 3 is prolonged: >450 ms (males) or >470 ms (females) as assessed by the central ECG interpretation (Visit 1) or investigator’s interpretation of the pre-dose ECGs (Visit 3). Patients who fail the screening ECG (with the exc
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