A Translational Study in Patients With COPD and Pre-COPD to Describe Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes That May Support Future Development of Personalized Treatment Strategies in Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 850
- 试验地点
- 15
- 主要终点
- Medical History
研究概览
简要总结
This is an observational study into more comprehensive understanding, including the trajectories of lung function decline, inflammatory/immunological mechanisms on pre-COPD or PRISm, clinical outcomes and relevant endotypes on physician-diagnosed COPD. The sponsor will follow up all participants for 1-year period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed ICF
- •Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society and European Respiratory Society 2019 acceptability criteria.
- •Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center.
- •Participants will be allowed to enroll into other non-intervention studies while taking part in this study.
排除标准
- •The participant has a history of alcohol or drug abuse within the past year, which, in the opinion of the responsible physician, contra-indicates their participation.
- •The participant has an altered mental status at the time of informed consent.
- •Clinically significant abnormal laboratory values available vital signs, ECG, or laboratory testing at the screening assessment that, which in the opinion of the investigator, could interfere with the objectives of the study or safety of the participant. -Current diagnosis of asthma.
- •Clinically important pulmonary disease.
- •COPD exacerbation, within 2 weeks prior to enrollment or during screening period.
- •History of partial or total lung resection (single lobe or segmentectomy is acceptable). Surgical or endoscopic (eg, valves) lung volume reduction within the 6 months prior to enrollment. Expected need for lung volume reduction surgery during the study.
- •Unstable disorders.
- •Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrollment. Suspected malignancy or undefined neoplasms.
- •Terminal disease and/or organ failure or participants otherwise considered not appropriate for the study participation.
- •Participants receipt marketed or investigational biologics biologics within 3 months or 5 half-lives prior to visit 1, whichever is longer.
- •Female participants who are pregnant.
研究组 & 干预措施
Cohort A
Healthy controls from asthma translational study: approximately 50 healthy participants aged 30 or older.
Cohort B
pre-COPD or PRISm: approximately 110 participants at 30 to 50 years of age (inclusive) with respiratory symptoms and/or structural lung lesions and/or physiological abnormalities without airflow obstruction (FEV1/FVC >= 0.7 post-bronchodilation). PRISm is defined as preserved ratio (FEV1/FVC >= 0.7 post-bronchodilation) with impaired spirometry (FEV1 < 80% of reference post-bronchodilation).
Cohort C1
Mild COPD (Cohort C): approximately 110 physician-diagnosed COPD participants in total with post-bronchodilation FEV1/FVC < 70% and FEV1 >= 80% of predicted. Cohort C1: participants at 30 to 50 years of age (inclusive).
Cohort C2
Mild COPD (Cohort C): approximately 110 physician-diagnosed COPD participants in total with post-bronchodilation FEV1/FVC < 70% and FEV1 >= 80% of predicted. Cohort C2: participants elder than 50 years of age (exclusive) within Cohort C mild COPD (approximately 110 total across C1 and C2).
Corhort D
Moderate to very severe COPD: approximately 330 COPD participants (males and females aged 50 years or older) with moderate to very severe airflow limitation defined as post-bronchodilation FEV1/FVC < 70% and FEV1 >= 25% and < 80% of predicted, and presence of respiratory symptoms equivalent to CAT >= 10 or mMRC >= 2.
结局指标
主要结局
Medical History
时间窗: At Baseline
Risk factors of COPD development or lung function decline
Occupation
时间窗: At Baseline
Risk factors of COPD development or lung function decline
Birth Status
时间窗: At Baseline
Risk factors of COPD development or lung function decline
Place of residence
时间窗: At Baseline
Risk factors of COPD development or lung function decline
Smoking history and status
时间窗: At Baseline to week 56
Risk factors of COPD development or lung function decline
Family history
时间窗: At Baseline
Risk factors of COPD development or lung function decline
SGRQ
时间窗: At Baseline to week 56
Measurement of questionnaires
CAT
时间窗: At Baseline to week 56
Measurement of questionnaires
MARS-5 (only applicable for COPD cohort)
时间窗: At Baseline to week 56
Measurement of questionnaires
Variables in COPD related medication, changes in medication
时间窗: At Baseline to week 56
Measurement of treatment pattern
FEV1 %
时间窗: At Baseline to week 56
Measurement of lung function
FEV1 /FVC
时间窗: At Baseline to week 56
Measurement of lung function
Forced Osc
时间窗: At Baseline to week 56
Measurement of lung function
FEF25-75
时间窗: At Baseline to week 56
Measurement of lung function
DLCO
时间窗: At Baseline to week 56
Measurement of lung function
WA%
时间窗: At Baseline to week 56
Measurement of lung structure profile and change through radiological parameters (CT scan)
Inflammatory differentials and counts in blood and BALF
时间窗: At Baseline to week 56
Measurement of inflammatory cell locally and systemically
Inflammatory cell infiltration
时间窗: At Baseline to week 56
Measurement of inflammatory cell locally and systemically
Exacerbation/respiratory history and event
时间窗: At Baseline to week 56
Measurement of disease control and burden
COPD related HRU
时间窗: At Baseline to week 56
Risk factors of COPD development or lung function decline
LAAinsp-950%
时间窗: At Baseline to week 56
Measurement of lung structure profile and change through radiological parameters (CT scan)
LAAexp-856%
时间窗: At Baseline to week 56
Measurement of lung structure profile and change through radiological parameters (CT scan)
MUC5B/MUC5AC
时间窗: At Baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
IL-33/ST2 complex
时间窗: At Baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
IL-33
时间窗: At Baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Air trapping index
时间窗: At Baseline to week 56
Measurement of lung structure profile and change through radiological parameters (CT scan)
hsCRP
时间窗: At baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Transcriptomic test in nasal, bronchial brushings, biopsies and BALF asmples
时间窗: At baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Proteomic test in blood, sputum, BALF and NLF samples
时间窗: At baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
次要结局
未报告次要终点