EUCTR2016-004655-75-FR进行中（未招募）1 期
A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Glycopyrronium/Formoterol Fumarate fixed-dose combination relative to Umeclidinium/Vilanterol fixed-dose combination over 24 Weeks in patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (AERISTO) - Aeristo
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,119
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. Provision of informed consent prior to any study specific procedures
- •2. Female or male patients aged 40-95 years inclusive at the time of enrolment at screening
- •3. Tobacco Use: Current or former smoker with a history of at least 10 pack-years of cigarette smoking (1 pack year = 20 cigarettes smoked per day for 1 year)
- •4. A current clinical diagnosis of COPD, with COPD symptoms for more than 1 year prior to screening, as defined by GOLD criteria or other current guidelines
- •5. COPD Severity defined as:
- •- At screening visits, post-bronchodilator FEV1/FVC ratio <0.70, FEV1 <80% of predicted normal value, and FEV1 =750 mL if FEV1 is <30% of predicted normal value
- •- At randomisation, FEV1/FVC ratio <0.70 and FEV1 <80% of predicted normal value in both pre-dose assessments
- •6. COPD treatment with rescue medication only, or stable dose of maintenance monotherapy (LAMA, LABA or ICS), or stable dose of double maintenance therapy (LAMA/LABA or ICS/LABA), for one month prior to screening. Triple maintenance therapy (LAMA/LABA/ICS) is not allowed for one month prior to screening. Stepping-down from triple maintenance therapy before the month prior to screening must only be based on clinical symptoms in the opinion of the Investigator
- •7. COPD symptom severity: CAT =10 at screening for patients on rescue medication only or maintenance monotherapy. No symptom requirement at screening for patients on double maintenance therapy. CAT =10 at randomisation for all patients
- •8. Patient is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol
- •9. Documentation of a chest x-ray (as per local practice) or computed tomography (CT) within 6 months prior to screening, with no clinically significant pulmonary abnormalities other than related to COPD
- •- Specific to countries with restrictive radiology assessment practice: if no documentation of chest x-ray or CT of the chest/lungs within 6 months prior to screening is available, an MRI may be used instead, as per local practice assessment, or the Investigator may follow local guidelines to have the chest x-ray or CT approved
- •10. Ability and willingness to comply with all study procedures, including daily completion of ePRO
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •1. Respiratory disease:
- •- Current diagnosis of asthma
- •- Alpha-1 Antitrypsin Deficiency as the cause of COPD
- •- Other respiratory disorders: active tuberculosis, lung cancer, clinically significant bronchiectasis disease, sarcoidosis, IPF, primary pulmonary hypertension, or uncontrolled sleep apnea
- •- Patients who have undergone lung volume reduction surgery, lobectomy or bronchoscopic lung volume reduction in 1yr of screening
- •- Severe COPD exacerbation (resulting in hospitalisation) not resolved in 8wk prior to screening, or moderate not resolved in 4wk, or moderate or severe during screening
- •- Pneumonia or lower respiratory tract infection that required antibiotics in 8wk prior to or during screening
- •- Risk factors for pneumonia: immune suppression (HIV), severe neurological disorders affecting control of the upper airway or other risk factors that would put patients at substantial risk of pneumonia
- •- Patients receiving long-term-oxygen therapy or nocturnal oxygen therapy required>12h/day
- •- Patient use of any non-invasive positive pressure ventilation device. Note: Patients using continuous positive airway pressure or bi-level positive airway pressure for sleep apnea syndrome are allowed if not used for ventilatory support
- •- Patients who have participated in the acute phase of a pulmonary rehabilitation in 4wk prior to screening or who will enter the acute phase of a pulmonary rehabilitation during screening. Allowed in the maintenance phase
- •2. Cardiac disease:
- •- Unstable angina/acute coronary syndrome, or CABG, PCI or myocardial infarction within the past 6 months.
- •- CHF NYHA class III/IV
- •- Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease)
- •- Paroxysmal (in past 6mths) or symptomatic chronic cardiac tachyarrhythmia
- •- LBB or high-degree AV block (2 and 3 degree) unless using pacemaker
- •- Sinus node dysfunction with pauses
- •- Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome
- •- QTcF interval >470 msec (corrected using Fridericia's formula)
- •- Any other ECG abnormality deemed clinically significant
- •- Bradycardia with ventricular rate <45bpm
- •- Uncontrolled hypertension >165/95mmHg
- •3. Patients with a calculated eGFR <30mL/min using CKD-EPI formula
- •4. Patients who have cancer that has not been in complete remission for at least 5yrs
- •5. Patients with a diagnosis of narrow-angle glaucoma that hasn't been adequately treated. All medications approved for control of intraocular pressures are allowed
- •6. Patients with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
- •7. Significant diseases or conditions other than COPD which may put the patient at risk, influence the results of the study or the patient's ability to participate
- •8. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalyses, vital signs or ECG which may put the patient at risk
- •9. Pregnant or lactating women, or if planning to become pregnant during the study, or women of childbearing potential who are not using an acceptable method of contraception
- •10. Patients who have a history of hypersensitivity to ß2 agonists, GP or other muscarinic anticholinergics, or any component of the MDI or DPI
- •11. Patients who abuse alcohol or drugs
- •12. Patients who are medically unable to withhold their short-acting bronchodilators for 6h prior to spirometry at study visits
- •13. Patients who would be unable to abstai
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