NCT04923347已完成4 期
Phase IV, 12-week, Single Arm, Open Label Study Evaluating the Safety and Efficacy of Fixed Dose Triple Combination FF/UMEC/VI Administered Once Daily in the Morning Via a Dry Powder Inhaler in Participants With Chronic Obstructive Pulmonary Disease in India
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs)
研究概览
简要总结
This study will evaluate safety and efficacy of FF/UMEC/VI via ELLIPTA® inhaler. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This will be an open-label study.
入排标准
- 年龄范围
- 40 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
- •Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- •Participants with a current diagnosis of asthma. (Participants with a prior history of asthma are eligible if they have a current diagnosis of COPD).
- •Documented (medical records) evidence of reversibility. Reversibility is defined as an increase in FEV1 of >=12 percent (%) and >=200 milliliter (mL) following administration of salbutamol. Participants defined as non-reversible will have a post-salbutamol increase in FEV1 of <200mL or a >=200mL increase that is <12% from pre-salbutamol baselineParticipants with alpha 1-antitrypsin deficiency as the underlying cause of COPD.
- •Participants with active tuberculosis, lung cancer, and clinically significant (in the opinion of the investigator): bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- •Participants with lung volume reduction surgery within the 12 months prior to Screening
- •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 and/or antibiotics (if applicable). In addition, any participant that experiences pneumonia and/or moderate or severe COPD exacerbation within the preceding two weeks prior to screening will be excluded.
- •Respiratory tract infection that has not resolved at least 7 days prior to Screening.
- •Participants with known COVID-19 positive contacts within the past 14 days should be excluded for at least 14 days since the exposure and the participant remains symptom free. Participants with symptoms suggestive of active COVID-19 infection e.g. fever, cough (new or worsened), etc. are also excluded.
- •Chest x-ray (poster anterior and lateral) 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 (CXR) (e.g. significant cardiomegaly, pleural effusion or scarring).
- •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.
- •Abnormal and clinically significant 12-lead electrocardiogram (ECG) finding at Visit
- •Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 Liters per minute (L/min) at screening (Oxygen use <=3L/min flow at rest is not exclusionary.)
- •Participants must not start the acute phase of a pulmonary rehabilitation program within the 4 weeks prior to Visit
- •Participants who are medically unable to withhold their salbutamol for the 4-hour period required prior to spirometry testing at each study visit.
- •In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete study related materials.
- •Use of the following medications within the following time intervals prior to Visit 1 or during the study:
- •Participants receiving antibiotics for long term therapy are not eligible for the study.
- •No use of systemic, Oral, parenteral corticosteroids within 30 days prior to screening (Intra-articular injections are allowed).
- •No use of any other investigational drug within 30 days or 5 half-lives whichever is longer prior to screening.
研究组 & 干预措施
Participants receiving FF/UMEC/VI via ELLIPTA inhaler
Experimental
干预措施: FF/UMEC/VI (Drug)
Participants receiving FF/UMEC/VI via ELLIPTA inhaler
Experimental
干预措施: ELLIPTA (Device)
结局指标
主要结局
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs)
时间窗: Up to approximately 40 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement. Protocol defined AESIs were included. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
次要结局
- Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85(Baseline (Day 1), Day 28 and Day 85)
研究者
研究点 (1)
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