CTIS2022-502274-16-00招募中1 期
A Double Blind, Multicentre, Randomised Three-Period, Three-Treatment, Cross-Over Study To Evaluate The Effect of BGF MDI, BFF MDI and Placebo MDI on Exercise Parameters In Participants with Chronic Obstructive Pulmonary Disease (ATHLOS) - D5988C00001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 299
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female, 40 to 80 years of age inclusive, at the time of signing the informed consent., Participant must have: (a) A diagnosis of Chronic obstructive pulmonary disease (COPD) confirmed by a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) < 0.7 at Visit 1. (b) A post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) = 30% and < 80% predicted normal (moderate to severe Chronic obstructive pulmonary disease (COPD)) at Visit 1. (c) A score of = 2 on the modified Medical Research Council (mMRC) at Visit 1. (d) Pre-bronchodilator Functional Residual Capacity (FRC) of > 120% of predicted normal FRC values at Visit 1., Participant must be on mono- or dual inhaled maintenance Chronic Obstructive Pulmonary Disease (COPD) treatment at a stable dose for 6 weeks (Long-Acting Muscarinic Antagonist (LAMA), Long-Acting Beta2-Agonist (LABA), Long-Acting Muscarinic Antagonist/ Long-Acting Beta2- Agonist (LAMA/LABA), or Inhaled Corticosteroid/ Long- Acting Beta2-Agonist (ICS/LABA))., Current or former smoker with a history of = 10 pack-years of tobacco smoking., Willing and, in the opinion of the investigator, able to adjust current Chronic Obstructive Pulmonary Disease (COPD) therapy, as required by the protocol (including Placebo periods)., Willing to visit at the study site as required per protocol to complete all visit assessments., A Body Mass Index (BMI) < 40 kg/m2 ., A female is eligible to enter and participate in the study if the female is of: (a) Non-childbearing potential: either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. A female will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply: (i) Female < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and follicle-stimulating hormone levels in the postmenopausal range. (ii) Female = 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. (b) Childbearing potential, has a negative serum pregnancy test at Visit 1 and must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. At enrollment, women of childbearing potential who are sexually active with a non-sterilized male partner should be stable on their chosen method of highly effective birth control, as defined below, and willing to remain on the birth control until at least 14 days after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. (c) Highly effective birth control methods include: - Sexual abstinence as defined as complete abstinence from intercourse when it is the preferred and usual lifestyle of the participant (however, periodic abstinence eg, calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception). - Contraceptive subdermal implant. - Intrauterine device or intrauterine system. - Oral contracept
排除标准
- •A current diagnosis of asthma, asthma-Chronic Obstructive Pulmonary Disease (COPD)-overlap, or any other chronic respiratory disease other than Chronic Obstructive Pulmonary Disease (COPD) such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease and pulmonary hypertension., A Chronic Obstructive Pulmonary Disease (COPD) exacerbation that requires hospitalization within 12 months prior to Visit 1 or a COPD exacerbation that requires systemic corticosteroids or antibiotics within 4 months of Visit 1., Participants with contraindications to cardiopulmonary exercise testing, including (but not limited to): (a) Acute myocardial infarction (within 6 months prior to Visit 1). (b) Unstable angina. (c) Uncontrolled arrhythmias, including atrial fibrillation with uncontrolled ventricular rate. (d) Active endocarditis. (e) Acute myocarditis or pericarditis. (f) Symptomatic aortic stenosis. (g) Uncontrolled heart failure. (h) Pulmonary embolism, uncontrolled pulmonary edema. (i) Acute non-cardiac disorder that may affect exercise performance or be aggravated by exercise (eg, infection, renal failure, thyrotoxicosis, acute bleeding, electrolyte abnormalities). (j) Left main coronary stenosis or equivalent. (k) Moderate or severe stenotic valvular cardiac disease. (l) Severe untreated arterial hypertension (> 200 mmHg systolic, > 120 mmHg diastolic). (m) Severe pulmonary hypertension. (n) Syncope tachyarrhythmias or bradyarrhythmias. (o) Hypertrophic cardiomyopathy. (p) Mental impairment leading to limited ability to perform study procedures. (q) High degree atrioventricular block. (r) Deep venous thrombosis of lower extremities. (s) Suspected dissecting aneurysm. (t) Participants with uncontrolled Type I diabetes mellitus., Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening period. . Participants who develop an upper or lower respiratory tract infection during the screening period will not be eligible, but will be permitted to be re-screened 8 weeks after the resolution of the respiratory tract infection., Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation., Unable to withhold short-acting bronchodilators for 6 hours prior to lung function testing at each study visit., Unable to abstain from protocol-defined prohibited medications., Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in this protocol is prohibited for use during the duration of the study)., Participants with a known hypersensitivity to beta2-agonists, muscarinic antagonists, or corticosteroids, or any component of the metered dose inhaler (MDI)., Participants with estimated Glomerular Filtration Rate (eGFR) = 30 mL/minute/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula., Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or Electrocardiogram (ECG), which in the opinion of the investigator, may put the participant at risk because of his/her participation in the study. Note: Participants with Electrocardiogram QT Interval Corrected for Heart Rate (ECG QTcF) interval > 480 msec will be excluded. Participants with h
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