EUCTR2007-003670-25-FR进行中（未招募）不适用
A randomized, double blind, placebo controlled, multicenter study to determine the effect of QVA149 on mean 24-hours heart rate in patients with Chronic Obstructive 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
- 250
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
- •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 according to the GOLD Guidelines (2006)
- •3. Patients who have smoking history of at least 10 pack years.
- •4. Patients with a post-bronchodilator FEV1 =30% and < 80% of the predicted normal and post-bronchodilator FEV1/FVC <0.70 at Visit 1 and 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
- •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 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 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL, OR are using one or more of the following acceptable methods of contraception:
- •surgical sterilization (e.g., bilateral tubal ligation, hysterectomy)
- •hormonal contraception (implantable, patch, oral)
- •double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) (if accepted by local regulatory authority and ethical committee)
- •Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
- •3. Patients requiring long term oxygen therapy (> 15 hr a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the screening period (up to Visit 4).
- •4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
- •5. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
- •6. Patients with any history of asthma
- •7. Patients with blood eosinophil count > 400/mm3
- •8. 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, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (excluding stable AF), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
- •9. Patients with a history of episodes of cardiac failure, life threatening arrhythmias as seen during screening Holter monitoring and evidence of acute ischemic changes during the screening ECGs
- •10. Patients with uncontrolled diabetes Type I or 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.
- •11. 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 the skin.
- •12. Patients who are contraindicated for or who have shown an untoward re
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A randomized, double blind, placebo controlled, multicenter study to determine the effect of QVA149 on mean 24-hours heart rate in patients with Chronic Obstructive Pulmonary Disease (COPD) - NDChronic obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10061877Term: Obstructive airways disorderEUCTR2007-003670-25-ITOVARTIS FARMA250