A phase IIIB, 24-week randomised, double-blind study to compare ‘closed’ triple therapy (FF/UMEC/VI) with 'open' triple therapy (FF/VI + UMEC), in subjects with chronic obstructive pulmonary disease (COPD) - 200812

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 个研究点目标入组 1,311 人开始时间: 2016年9月29日最近更新: 2021年12月21日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 1,311

研究概览入排标准研究者记录与标识符相似试验

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

•Subjects eligible for enrolment in the study must meet all of the following criteria:
•1. Informed Consent: A signed and dated written informed consent prior to study participation.
•2. Type of subject: Outpatient.
•3. Age: Subjects 40 years of age or older at Screening (V1).
•4. Gender: Male or female subjects.
•A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies:
•a. Non-reproductive potential defined at the paragrapgh 5.1 in the protocol.
•b. Reproductive potential and agrees to follow one of the options listed in the Appendix 5 of the protocol from 30 days prior to the first dose of study treatmentand until after the last dose of study
•treatmentand completion of the follow-up visit.
•5. COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European
•Respiratory Society [Celli, 2004].
•6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of =10 pack-years at Screening.
•7. Severity of COPD symptoms: A score of =10 on the COPD Assessment Test (CAT) at Screening (V1).
•8. Severity of COPD Disease: A post-albuterol/salbutamol FEV1/FVC ratio of <0.70
•at Screening (V1).
•9. Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior
•to Screening (V1).
•10. History of Exacerbations: Subjects must demonstrate:
•a post-bronchodilator FEV1 < 50% predicted normal at Screening (V1) and a documented history of = 1 moderate or severe COPD exacerbation
•in the 12 months prior to Screening
•a post-bronchodilator 50% =FEV1 < 80% predicted normal at Screening (V1) and a documented history of = 2 moderate exacerbations or a
•documented history of =1 severe COPD exacerbation (hospitalised) in the 12 months prior to
•Screening (V1).
•11. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social securitycategory.
•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 510
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 510

排除标准

•1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
•2. Asthma: Subjects with a current diagnosis of asthma.
•3. a1-antitrypsin deficiency: Subjects with a1-antitrypsin deficiency as the underlying cause of COPD.
•4. Other respiratory disorders: Subjects with active tuberculosis are excluded. Subjects with other respiratory disorders are excluded if these
•conditions are the primary cause of their respiratory symptoms.
•5. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening.
•6. Risk Factors for Pneumonia: immune suppression or other risk factors for pneumonia.
•7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days
•following the last dose of oral/systemic corticosteroids.
•8. Other Respiratory tract infections that have not resolved at least 7 days prior to Screening
•9. Abnormal Chest x-ray: Chest x-ray reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence
•of COPD, or another condition that would hinder the ability to detect an infiltrate on chest x-ray. All subjects will have a chest x-ray at Screening
•(V1) [or historical radiograph or CT scan obtained within 3 months prior to Screening.
•10. Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric,
•renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine or haematological
•abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the
•subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
•11. Unstable liver disease: ALT >2xULN; and bilirubin >1.5xULN
•Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver
•disease per investigator assessment).
•12. Unstable or life threatening cardiac disease: subjects with any of the following at Screening (V1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; NYHA Class IV Heart failure
•13 An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is
•interpreted as, but not limited to, any of the following: AF with rapid ventricular rate >120 BPM;
•sustained or nonsustained VT; Second degree heart block Mobitz type II and third degree heart block.
•14. Contraindications: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2- agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or
•bladder neck obstruction that, in the opinion of the investigator contraindicates study participation.
•15. Cancer: Subjects with carcinoma that has not been in complete remission for at least 3 years. Subjects who have had carcinoma in situ
•of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 3 year waiting period if the
•subject has been considered cured

研究者

发起方

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT

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