EUCTR2013-004223-37-DE进行中（未招募）不适用
A randomized, multicenter, open-label, cross-over study to assess lung function and patient preference after a 4 week treatment each with QVA149 vs. tiotropium in patients with stable chronic obstructive pulmonary disease (COPD) and moderate to severe airflow limitation who are on a tiotropium therapy - FAVOR
ovartis Pharma GmbH0 个研究点开始时间: 2014年2月4日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
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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 and female adults aged =40 years.
- •2.Patients who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- •3.Patients with stable COPD according to current guidelines (GOLD 2013).
- •4.Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of <0.70 and a post-bronchodilator FEV1 of =30% and <80% of predicted normal values at Visit 2.
- •5.Current or ex-smokers who have a smoking history of at least 10 pack years (10 pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.). An ex-smoker may be defined as a subject who has not smoked for = 6 months at Visit 1 (Screening).
- •6.Patients on stable tiotropium (18 µg/d) monotherapy (tiotropium monotherapy + ICS is allowed) administered via HandiHaler® and adherent, with good device technique for at least 8 weeks before Visit 1 (Screening).
- •7.Symptomatic patients defined as patients with CAT score = 10 at Visit 1 (Screening).
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •1.Pregnant or breast feeding mothers (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5mIU/ml)).
- •2.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception (Pearl Index <1) during the study and up to at least 4 weeks after the end of treatment. 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/m OR 6 weeks after surgical bilateral oophorectomy (with or without hysterectomy).
- •3.Patients with conditions 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
- •4.Patients with a history of clinically significant diseases that, in the opinion of the investigator, would put the safety of the patients at risk through study participation, or would compromise patient compliance or preclude completion of the study.
- •5.Patients who have a clinically significant renal disease (moderate to severe renal impairment GFR < 50 ml/min/1.73 m2).
- •6.Patients with myocardial infarctions less than 6 months prior to study entry.
- •7.Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.
- •8.Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction 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).
- •9.Patients with a 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. Patients with non-melanoma skin carcinoma may be considered for the study.
- •10.Patients with neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which, in the opinion of the investigator, could interfere with the assessment of the efficacy and safety of the study treatment.
- •11.Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.
- •12.Patients with a body mass index (BMI) of more than 40 kg/m2.
- •13.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
- •14.Patients, who have already been randomized into this trial earlier must not be included a second time.
- •15.Study personnel or first degree relatives of investigator(s) must not be included in the study.
- •16.Patients incapable of giving full informed consent.
- •COPD specific exclusion
- •17.Patients who are receiving LABA or a PDE-4 inhibitor less than 8 weeks prior to Visit 1.
- •18.Patients requiring long term oxygen therapy (>12 h a day) on a daily basis for chronic hypoxia.
- •19.Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids and/or hospitalization in the 6
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