EUCTR2019-002744-24-GB进行中（未招募）1 期
A phase IV, open label, multicentre, randomised, 2-way cross-over exploratory clinical trial comparing a fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrronium administered via pMDI (TRIMBOW®) and a fixed combination of fluticasone furoate plus vilanterol administered via DPI (RELVAR® ELLIPTA®) on lung stiffness reduction assessed through area under the reactance curve (AX) using forced oscillation technique (FOT) in patients with chronic obstructive pulmonary disease (COPD). - CLI-05993AA1-21 - TRIMBOW Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- •- Patients with established diagnosis of COPD at least 12 months prior to the screening visit (according to GOLD Report, revised 2019). Patients with a diagnosis of Asthma COPD Overlap Syndrome (ACOS) and with a current diagnosis of atopy or allergic rhinitis based on their medical history and investigator judgement will be also eligible for inclusion.
- •- Current smokers or ex-smokers, who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20]. If patients underwent any kind of smoking cessation therapy, it should be finished at least 2 months prior to screening.
- •- 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.
- •- Patients under double or triple therapy for at least 2 months prior to screening visit in stable doses and regimens with either:
- •a.inhaled corticosteroids/long-acting ß2-agonist combination (ICS/LABA) (fixed or free), or
- •b.inhaled corticosteroids/long-acting muscarinic antagonist free combination (ICS/LAMA), or
- •c.Inhaled long-acting ß2-agonist / long-acting muscarinic antagonist (LABA/LAMA) (fixed or free), or
- •d.fixed or free combination of an inhaled corticosteroid /long-acting ß2-agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA)
- •- A cooperative attitude and ability to correctly use the study inhalers and spacer.
- •- Female patients must be either of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) or physiologically capable of becoming pregnant (i.e. women of childbearing potential (WOCBP) fulfilling one of the following criteria:
- •a.WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up contact or
- •b.WOCBP with non-fertile male partners (contraception is not required in this case).
- •For the definition of WONCBP, WOCBP, fertile men, and the list of highly effective birth control methods, refer to Appendix 3 (or section 4.1 of the CTFG guidance).
- •Any postmenopausal women (physiologic menopause defined as 12
- •consecutive months of amenorrhea”) or women permanently sterilized (e.g. bilateral oophorectomy, hysterectomy or bilateral salpingectomy) may be enrolled in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •- Diagnosis of asthma.
- •- Patients requiring use of the following medications:
- •i.A course of systemic steroids longer than 3 days for COPD exacerbation in the 4 weeks prior to screening.
- •ii.A longer than 7-day course of antibiotics for the treatment of COPD exacerbation in the 4 weeks prior to screening.
- •iii.Use of antibiotics for a lower respiratory tract infection (e.g pneumonia) in the 4 weeks prior to screening.
- •- COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period.
- •- Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
- •- Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator’s judgment. This can include but is not limited to alfa-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
- •- Patients who have clinically severe cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV, left ventricular failure, acute myocardial infarction, not controlled arrhythmia etc.), which may impact the efficacy or the safety of the study drug according to the investigator’s judgement.
- •- An abnormal and clinically significant 12-lead ECG which may impact the safety of the patient according to investigator’s judgement. Patients whose electrocardiogram (ECG) (12 lead) shows QTcF >450 ms for males or QTcF >470 ms for females at screening or at randomisation visits are not eligible. The QTcF criterion should not be applicable to patients with pacemaker or permanent atrial fibrillation.
- •- 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.
- •- 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 judgement.
- •- 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.
- •- Unstable concurrent disease: e.g. fever, 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.
- •- History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit.
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