EUCTR2013-005268-25-DE进行中（未招募）不适用
A MULTINATIONAL, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO-CONTROLLED , 2-WAY CROSSOVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5259), FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
CHIESI FARMACEUTICI SPA0 个研究点目标入组 140 人开始时间: 2014年3月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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. Patients with a diagnosis of COPD at least 12 months before the
- •screening visit (according to GOLD guidelines, revised February 2013).
- •3. Current smokers or ex-smokers who quit smoking at least 6 months
- •prior to the screening visit.
- •4. A post-bronchodilator FEV1 < 60% of the predicted normal value and
- •a post-bronchodilator FEV1/FVC < 0.7 within 30 min after 4 puffs (4 x
- •100 µg) of salbutamol pMDI.
- •5. Patients with a positive response to the reversibility test at screening
- •within 30 minutes after administration of 400 µg (4 x 100 µg) of
- •salbutamol pMDI, defined as ?FEV1 = 5%.
- •6. Symptomatic patients at screening with a BDI focal score = 10.
- •7. Patients treated with double therapy for at least 1 month prior to
- •screening visit with either:
- •a. inhaled corticosteroids/long-acting ß2-agonist combination treatment
- •(fixed and/or free);
- •b. inhaled corticosteroids/long-acting muscarinic antagonist
- •combination.
- •8. Patients free of exacerbations for at least 1 month prior to screening
- •and during the run-in period.
- •9. A cooperative attitude and ability to be trained to use correctly the
- •pMDI inhaler.
- •10. A cooperative attitude and ability to be trained to use correctly the
- •electronic devices with COPD questionnaires.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Inability to carry out pulmonary lung function testing, to comply with
- •study procedures or with study treatment intake.
- •2. Pregnant or lactating women and all women physiologically capable of
- •becoming pregnant (i.e. women of childbearing potential) UNLESS are
- •willing to use one or more of the reliable methods of
- •contraception.
- •3. Diagnosis of asthma or medical history of asthma.
- •4. Patients treated with long-acting antihistamines unless taken at
- •stable regimen at least 2 months prior to screening and to be maintained
- •constant during the study or if taken as PRN.
- •5. Use of antibiotics for a lower respiratory tract infection in the 4 weeks
- •prior to screening and during run-in period.
- •6. Patients requiring long term (at least 12 hours daily) oxygen therapy
- •for chronic hypoxemia.
- •7. Known respiratory disorders other than COPD which may impact the
- •efficacy or the safety of the study drug according to investigator's
- •8. Patients who have a clinically significant cardiovascular condition
- •according to investigator's judgement
- •9. Patient with persistent, long standing persistent or permanent atrial fibrillation.
- •10. An abnormal and clinically significant 12-lead ECG which may impact
- •the safety of the patient according to investigator's judgement.
- •11. Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy
- •or bladder neck obstruction that in the opinion of the investigator would
- •prevent use of anticholinergic agents.
- •12. History of hypersensitivity to anticholinergics, ß2-agonist,
- •corticosteroids or any of the excipients contained in any of the
- •formulations used in the trial which may raise contra-indications or
- •impact the efficacy of the study drug according to the investigator's
- •13. Clinically significant laboratory abnormalities indicating a significant
- •or unstable concomitant disease which may impact the efficacy or the
- •safety of the study drug according to investigator's judgement.
- •14. Patients with serum potassium levels <3.5 mEq/L (or 3.5 mmol/L)
- •or > 5.5 mEq/L (or 5.5 mmol/L).
- •15. Unstable concurrent disease: e.g. uncontrolled hyperthyroidism,
- •uncontrolled diabetes mellitus or other endocrine disease; significant
- •hepatic impairment; significant renal impairment; uncontrolled
- •gastrointestinal disease (e.g. active peptic ulcer); uncontrolled
- •neurological disease; uncontrolled haematological disease; uncontrolled
- •autoimmune disorders, or other which may impact the efficacy or the
- •safety of the study drug according to investigator's judgment.
- •16. History of alcohol abuse and/or substance/drug abuse within 12
- •months prior to screening visit.
- •17. Participation in another clinical trial where investigation drug was
- •received less than 8 weeks (or 5 half-lives for biologic products with
- •slow elimination) prior to screening visit.
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