EUCTR2011-003588-31-HU进行中（未招募）不适用
A multicentre, randomised, double-blind, active-controlled, 4-way cross-over study to evaluate the efficacy and safety of a free combination of 3 doses of Glycopyrrolate with fixed combination Beclomethasone Diproprionate plus Formoterol (Foster®) in a metered dose inhaler for the treatment of patients with Chronic Obstructive Pumlonary Disease (COPD)
适应症
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
- 180
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 and female adults (40 = age = 80 years) with written informed consent obtained prior to any study-related procedure.
- •2. Outpatients with a diagnosis of COPD (according to GOLD guidelines) with:
- •A smoking history of at least 10 pack years (pack-years = ((number of cigarettes per day x number of years)/20). Current and ex-smokers are eligible.
- •(Smoking cessation therapy must be completed within 3 months prior to screening visit and smoking status shall not change after screening and during the study period)
- •- A Post-bronchodilator 30%=FEV1<60% of the predicted normal value
- •- A Post-bronchodilator FEV1/FVC < 0.7
- •- An increase from baseline of FEV1 value 30 min after 80µg ipratropium of at least 60mL
- •3. Patients treated with double therapy with inhaled corticosteroids/long-acting ß-agonist combination or with triple therapy with inhaled corticosteroids/long-acting ß-agonist combination and long-acting anticholinergic (tiotropium) if taken for not more than one month at stable regimen before screening.
- •4. A cooperative attitude and ability to be trained to use correctly the pMDI inhalers.
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 108
排除标准
- •1.Pregnant or lactating women.
- •In case of childbearing potential, patients and/or their partner must be willing to use an approved method of contraception unless they meet the post-menopausal definition (amenorrhea>12 Mo or >6 Mo with FSH >40 mIU/ml). Methods of contraception may include one or more of the following ones: Surgical sterilization, hormonal contraception, double-barrier methods and periodic abstinence
- •Reliable contraception should be maintained throughout the study.
- •2.Diagnosis of asthma or history of allergic rhinitis or atopy.
- •3.Participation in another clinical trial where investigation drug was received less than 8 weeks prior to first intake of the study medication.
- •4.Hospitalisation for COPD or pneumonia within 3 month prior to screening
- •5.Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics in the 4 weeks prior to screening and during the run-in period.
- •6.Patients treated with oral/parenteral ß2-agonists or nebulised bronchodilators or PDE inhibitors in the 4 weeks prior to screening and during the run-in period.
- •7.Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening and during the run-in period.
- •8.Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
- •9.Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
- •10.Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic.
- •11.History of hypersensitivity to M3 Antagonists, ß2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial.
- •12.History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit
- •13.An abnormal and clinically significant 12-lead ECG that results in active medical problem.
- •14.Electrocardiogram (ECG) (12 lead) with QTcF >450 ms for males or QTcF > 470 ms for females.
- •15.Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the feasibility of the results of the study according to investigator’s judgement.
- •16.Patients with serum potassium levels < 3.5 mEq/L (or 3.5 mmol/L).
- •17.Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. uncontrolled coronary artery disease, uncontrolled hypertension); uncontrolled gastrointestinal disease (e.g. active peptic ulcer); neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the feasibility of the results of the study according to investigator’s judgment.
- •18.Evidence of heart failure (NYHA class IV).
- •19.Changes in dose, schedule, formulation or product of oral xanthine derivatives (eg theophylline) in the three months prior to screening visit.
- •20.Change in dose, schedule, formulation or product of ß-blockers in the month prior to screening.
研究者
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