NCT04937387已完成3 期
A Phase III, 12 Week, Randomized, Double-blind, 4 Arm Parallel Group Bridging Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI Once-daily Via a Dry Powder Inhaler With Dual Combination of FF/VI, Administered in Chinese Participants With Inadequately Controlled Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 359
- 试验地点
- 1
- 主要终点
- Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (100ug FF)
研究概览
简要总结
The study aims to evaluate the efficacy, safety and tolerability of FF/UMEC/VI compared with FF/VI via ELLIPTA® inhaler in Chinese participants with inadequately controlled asthma. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Chest X-ray documented pneumonia in the 6 weeks prior to Visit
- •Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit
- •Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, including all of the following:
- •History of exposure to risk factors (especially tobacco smoke, occupational dusts and chemicals, smoke from home cooking and heating fuels).
- •A post-albuterol/salbutamol FEV1/Forced Vital Capacity (FVC) ratio of <0.70 and a post-albuterol/salbutamol FEV1 of less than or equal to (<=)70% of predicted normal values.
- •Onset of disease >=40 years of age.
- •Participants with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
- •Immune suppression (e.g., Human Immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g., neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Participants at potentially high risk (e.g., very low Body Mass Index [BMI], severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.
- •Participants with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- •Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •Clinically significant Electrocardiogram (ECG) abnormality: Evidence of a clinically significant abnormality in the 12-lead ECG performed during screening. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the participant's medical history and exclude participants who would be at undue risk by participating in the trial. An abnormal and clinically significant finding is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following:
- •Atrial Fibrillation with rapid ventricular rate >120 beats per minute (bpm).
- •Sustained or non-sustained ventricular tachycardia.
- •Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted).
- •QT interval corrected for heart rate by Fridericia's formula (QTcF) >=500 milliseconds (msec) in participants with QRS <120 msec and QTcF >=530 msec in participants with QRS >=120 msec.
- •Participants with any of the following at Screening (Visit 1):
- •Myocardial infarction or unstable angina in the last 6 months.
- •Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months.
- •New York Heart Association (NYHA) Class IV Heart failure [American Heart Association, 2016].
- •Participants with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the Investigator the benefit outweighs the risk and that the condition would not contraindicate study participation.
- •Participants with carcinoma that has not been in complete remission for at least 5 years. Participants 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 5 year waiting period if the participant has been considered cured by treatment.
- •Participants with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
- •Participants who are medically unable to withhold their albuterol/salbutamol for the 6-hour period required prior to spirometry testing at each study visit.
- •Participants who are:
- •Current smokers (defined as participants who have used inhaled tobacco products within the 12 months prior to Visit 1, e.g. cigarettes, electronic-cigarettes/vaping, cigars or pipe tobacco).
- •Former smokers with a smoking history of >=10 pack years (e.g. >=20 cigarettes per day for 10 years).
- •Participants with a known or suspected history of alcohol or drug abuse within the last 2 years.
- •A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate.
- •Participants at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
- •Study Investigators, sub-Investigators, study coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study.
- •In the opinion of the Investigator, any participant who is unable to read and/or would not be able to complete study related materials.
- •Inclusion criteria for randomization:
- •Participants with inadequately controlled asthma (ACQ-6 score >=1.5) at Visit
- •A best pre-bronchodilator morning (AM) FEV1 >=30% and <90% of the predicted normal value at Visit
- •Predicted values will be based upon the ERS Global Lung Function Initiative (Quanjer).
- •Liver function tests at Visit 1:
- •Alanine aminotransferase (ALT) <2 times upper limit of normal (ULN).
- •Alkaline phosphatase <=1.5 times ULN.
- •Bilirubin <=1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •Compliance with completion of the Electronic diary reporting defined as completion of all questions/assessment on >=4 of the last 7 days during the run-in period.
- •Exclusion criteria for randomization:
- •Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the participant's asthma status or the participant's ability to participate in the study.
- •Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
- •Changes in asthma medication (excluding run-in medication and albuterol/salbutamol inhalation aerosol provided at Visit 1).
- •Evidence of clinically significant abnormal laboratory tests during screening or run-in which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality.
研究组 & 干预措施
Cohort 3: Participants receiving FF/ VI at Dose level 3 via ELLIPTA inhaler
Experimental
干预措施: ELLIPTA (Device)
Cohort 3: Participants receiving FF/ VI at Dose level 3 via ELLIPTA inhaler
Experimental
干预措施: FF/VI (Drug)
Cohort 1: Participants receiving FF/VI at Dose level 1 via ELLIPTA inhaler
Experimental
干预措施: FF/VI (Drug)
Cohort 1: Participants receiving FF/VI at Dose level 1 via ELLIPTA inhaler
Experimental
干预措施: ELLIPTA (Device)
Cohort 2: Participants receiving FF/UMEC/VI at Dose level 2 via ELLIPTA inhaler
Experimental
干预措施: FF/UMEC/VI (Drug)
Cohort 2: Participants receiving FF/UMEC/VI at Dose level 2 via ELLIPTA inhaler
Experimental
干预措施: ELLIPTA (Device)
Cohort 4: Participants receiving FF/UMEC/VI at Dose level 4 via ELLIPTA inhaler
Experimental
干预措施: FF/UMEC/VI (Drug)
Cohort 4: Participants receiving FF/UMEC/VI at Dose level 4 via ELLIPTA inhaler
Experimental
干预措施: ELLIPTA (Device)
结局指标
主要结局
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (100ug FF)
时间窗: Baseline (pre-dose at Day 1) and Week 12
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the latest acceptable assessment with non-missing value at the randomization visit (Visit 2).
次要结局
- Change From Baseline in Trough FEV1 at Week 12 (200ug FF)(Baseline (pre-dose at Day 1) and Week 12)
- Change From Baseline in Asthma Control Questionnaire (ACQ-7) Total Score at Week 12(Baseline (pre-dose at Day 1) and Week 12)
研究者
研究点 (1)
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