EUCTR2010-022721-14-DE进行中（未招募）不适用
A randomized, blinded, double-dummy, multi-center, placebo controlled, 3 period, cross-over study to assess the effect of QVA149 (110/50 µg o.d.) on exercise endurance in patients with moderate to severe chronic obstructive pulmonary disease (COPD), using tiotropium as an active control - n/a
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
- •Patients with moderate to severe stable COPD (Stage II or Stage III) according to the GOLD Guidelines 2009
- •Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- •Patients with a post-bronchodilator FEV1 =40% and <70% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2
- •[Post refers to 1 h after sequential inhalation of the equivalent of 84 µg (ex valve) or 17 µg (ex-mouthpiece) of ipratropium bromide and 400 µg of salbutamol base)]
- •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
- •Pregnant women (confirmed by positive urine pregnancy test) or nursing mothers.
- •Women of child-bearing potential [further defined in protocol], unless specific
- •Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
- •anticholinergic agents
- •long and short acting beta-2 agonists
- •sympathomimetic amines.
- •lactose or any of the other excipients
- •Patients with a history of long QT syndrome or whose QTc measured at screening (Fridericia method) is prolonged (>450 ms for males and females) as confirmed by the central ECG assessor.
- •Patients who have a clinically significant abnormality on the screening ECG who in the judgment of the investigator would be at potential risk if enrolled into the study. (These patients should not be re-screened).
- •Patients who have not achieved an acceptable spirometry result at Visit 2 in accordance with ATS/ERS criteria for acceptability and repeatability
- •Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at Visit 2.
- •Patients with contraindications to cardiopulmonary exercise testing
- •Patients with resting (5 min) oxygen SaO2 saturation on room air of <85%
- •Patients who do not maintain regular day/night, waking/sleeping cycles (e.g. night shift workers).
- •Patients whose endurance in the exercise test is limited by non-respiratory conditions e.g. by neurologic, orthopedic, or other disorders
- •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 the skin.
- •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. Patients with a transurethral resection of prostate (TURP) are excluded from the study. Patients who have undergone full re-section of the prostate may be considered for the study, as well as patients who are asymptomatic and stable on pharmacological treatment for the condition.
- •Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia or who experience oxygen desaturation <80% during cycle exercise on room air.
- •Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4.
- •[other exclusion criteria are defined in the protocol]
研究者
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