A Translational Study for Prediction of Biomarkers and Identification of Phenotype and Endotype of COPD and Early COPD Outcomes in Chinese Population

AstraZeneca

Status: Enrolling

Conditions: COPD

Study type: Observational

Funder types: Industry

Identifiers

NCT06724848

D2287R00187

Details and patient eligibility

About

This is an observational study into more comprehensive understanding, including the trajectories of lung function decline, inflammatory/immunological mechanisms on early COPD, clinical outcomes and relevant endotypes on physician-diagnosed COPD. The sponsor will follow up all participants initially for 1-year period. The follow-up period may extend up to 3 years depending upon emerging data and feasibility assessment by the sponsor.

Enrollment: 850 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 studies while taking part in this study. However, permission from the Steering Committee must be obtained to enroll or allow the continued participation of a participant enrolled in another study.

Exclusion criteria

• 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 according to the Global Initiative for Asthma or other accepted guidelines, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved (ie, not requiring the use of any maintenance or rescue medication) before the age of 18.
• Clinically important pulmonary disease (as discretion by local physician) other than COPD (eg, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 anti-trypsin deficiency, and primary ciliary dyskinesia).
• COPD exacerbation, within 2 weeks prior to enrollment, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization (based on last dose of corticosteroids or antibiotics, or last date of hospitalization, whichever occurred later).
• 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, including, but not limited to, autoimmune disease, diabetes, thyroid disease, significant cardio-renal disease (including significant hypertension, atrial fibrillation, hypertrophic cardiomyopathy, and significant cardiovascular disease).
• 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 investigational biologics within 3 months or 5 half-lives prior to visit 1, whichever is longer.
• Participants who are actively enrolled in an interventional clinical trial.
• Female participants who are pregnant.

Trial design

850 participants in 5 patient groups

Cohort A

Description:

Healthy controls from asthma translational study: at least 50 healthy participants aged 30 or older.

Cohort B

Description:

early COPD, normal lung function with symptoms approximately 200 smokers or ex-smokers, early COPD participants at 30 to 45 years of age (inclusive) with normal lung function defined as FEV1/FVC ratio \> 70% (lower limit of normal) and FEV1 \> 80% of predicted normal with symptoms defined as presence of chronic cough and/or chronic sputum and/or breathlessness equivalent to mMRC Grade 1 or higher, with any of the risk factors below: * History suggestive of COPD exacerbation; * Evidence of emphysema on CT scan; * Evidence of small airways disease on CT scan or oscillometry.

Cohort C1

Description:

Approximately 100 physician diagnosed COPD participants with mild airflow limitation defined as post-bronchodilation FEV1/FVC \< 70% and FEV1 ≥ 80% of predicted. Participants at 30 to 50 years of age (inclusive)

Cohort C2

Description:

Approximately 100 physician diagnosed COPD participants with mild airflow limitation defined as post-bronchodilation FEV1/FVC \< 70% and FEV1 ≥ 80% of predicted. Defined as participants elder than 50 years of age (exclusive)

Corhort D

Description:

Moderate to very severe COPD Approximately 450 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 quivalent to CAT ≥ 10 or mMRC ≥ 2.