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

Official title

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

Overview

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.

Primary outcome measures

• Medical History [Time frame: At Baseline]
• Occupation [Time frame: At Baseline]
• Birth Status [Time frame: At Baseline]
• Place of residence [Time frame: At Baseline]
• Smoking history and status [Time frame: At Baseline to week 56]
• Family history [Time frame: At Baseline]
• Exacerbation/respiratory history and event [Time frame: At Baseline to week 56]
• COPD related HRU [Time frame: At Baseline to week 56]
• SGRQ [Time frame: At Baseline to week 56]
• CAT [Time frame: At Baseline to week 56]

Eligibility criteria

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 non-intervention studies while taking part in this 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 14 centers

• Research Site — Beijing
• Research Site — Changsha
• Research Site — Chengdu
• Research Site — Guangzhou
• Research Site — Hefei
• Research Site — Nanjing
• Research Site — Nanning
• Research Site — Shanghai
• … and 6 more centers

Identifiers

NCT: NCT06724848 · D2287R00187

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗