EUCTR2009-013235-38-HU进行中（未招募）不适用
A multicenter, randomized, double-blind, placebocontrolledstudy, to assess the long term safety of 52weeks treatment with QVA149 (110µg indacaterol / 50µgglycopyrrolate) in patients with moderate to severe ChronicObstructive Pulmonary Disease (COPD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 339
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1. Male or female adults aged =40 years, who have signed an Informed Consent Form
- •prior to initiation of any study-related procedure
- •2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the
- •[GOLD Guidelines 2008]
- •3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten
- •pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20
- •years etc.)
- •4. Patients with post-bronchodilator FEV1 = 30% and <80% of the predicted normal, and
- •post-bronchodilator FEV1/FVC 0.7 at Visit 2
- •(Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of
- •ipratropium bromide and 400 µg of salbutamol or equivalent dose of albuterol)
- •5. Patients, according to daily electronic diary data between Visit 2 and Visit 3, with a
- •total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.
- •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
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine
- •pregnancy test).
- •2. Women of child-bearing potential (WOCBP), 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 post-menopausal: 12 months of natural (spontaneous) amenorrhea OR 6
- •weeks after surgical bilateral oophorectomy (with or without hysterectomy) OR are
- •using one or more of the following acceptable methods of contraception:
- •surgical sterilization (e.g. bilateral tubal ligation),
- •hormonal contraception (implantable, patch, oral, IM) and copper coated IUD, if
- •accepted by local regulatory authority and ethics committee,
- •double barrier method (diaphragm plus condom),
- •At the discretion of the investigator, total abstinence is acceptable in cases where
- •the age, career, lifestyle, or sexual orientation of the patient ensures compliance
- •Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation
- •methods) and withdrawal are not acceptable methods of contraception.
- •Note: Reliable contraception should be maintained throughout the study.
- •3. Patients requiring long term oxygen therapy (> 15h a day) on a daily basis for chronic
- •4. Patients who have had a COPD exacerbation that required treatment with antibiotics or
- •oral steroids or hospitalization in the 6 weeks prior to Visit 1 or between Visit 1 and
- •5. Patients who develop a COPD exacerbation during the period between Visits 1 and 3
- •will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks
- •after the resolution of the COPD exacerbation
- •6. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
- •Patients who develop an upper or lower tract infection during the screening period (up
- •to Visit 3) will not be eligible, but will be permitted to be re-screened 4 weeks after the
- •resolution of the respiratory tract infection)
- •7. Patients with concomitant pulmonary disease, e.g., pulmonary tuberculosis (unless
- •confirmed by chest x-ray to be no longer active) or clinically significant
- •bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension.
- •8. Patients with lung lobectomy, or lung volume reduction or lung transplantation.
- •9. 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, left ventricular failure, history of myocardial
- •infarction, arrhythmia (excluding chronic stable AF)
- •history of malignancy of any organ system (including lung cancer), treated or
- •untreated, within the past 5 years whether or not there is evidence of local
- •recurrence or metastases, with the exception of localized basal cell carcinoma of
- •Uncontrolled hypo- or hyperthyroidism, hypokalemia or hyperadrenergic state
- •narrow-angle glaucoma
- •symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to
- •severe renal impairment or urinary retention
- •any condition which might compromise patient safety or compliance, interfere
- •with evaluation, or preclude completion of the study
- •10. Patients with any history of asthma indicated b
研究者
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