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

NCT06724848 | Recruiting

• 1 other identifier: D2287R00187
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (29)

• Medical History

  Risk factors of COPD development or lung function decline

  At Baseline

• Occupation

  Risk factors of COPD development or lung function decline

  At Baseline

• Birth Status

  Risk factors of COPD development or lung function decline

  At Baseline

• Place of residence

  Risk factors of COPD development or lung function decline

  At Baseline

• Smoking history and status

  Risk factors of COPD development or lung function decline

  At Baseline to week 56

• Family history

  Risk factors of COPD development or lung function decline

  At Baseline

• Exacerbation/respiratory history and event

  Measurement of disease control and burden

  At Baseline to week 56

• COPD related HRU

  Risk factors of COPD development or lung function decline

  At Baseline to week 56

• SGRQ

  Measurement of questionnaires

  At Baseline to week 56

• CAT

  Measurement of questionnaires

  At Baseline to week 56

• MARS-5 (only applicable for COPD cohort)

  Measurement of questionnaires

  At Baseline to week 56

• Variables in COPD related medication, changes in medication

  Measurement of treatment pattern

  At Baseline to week 56

• FEV1 %

  Measurement of lung function

  At Baseline to week 56

• FEV1 /FVC

  Measurement of lung function

  At Baseline to week 56

• Forced Osc

  Measurement of lung function

  At Baseline to week 56

• FEF25-75

  Measurement of lung function

  At Baseline to week 56

• DLCO

  Measurement of lung function

  At Baseline to week 56

• LAAinsp-950%

  Measurement of lung structure profile and change through radiological parameters (CT scan)

  At Baseline to week 56

• LAAexp-856%

  Measurement of lung structure profile and change through radiological parameters (CT scan)

  At Baseline to week 56

• WA%

  Measurement of lung structure profile and change through radiological parameters (CT scan)

  At Baseline to week 56

• Inflammatory differentials and counts in blood and BALF

  Measurement of inflammatory cell locally and systemically

  At Baseline to week 56

• Inflammatory cell infiltration

  Measurement of inflammatory cell locally and systemically

  At Baseline to week 56

• MUC5B/MUC5AC

  Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm

  At Baseline to week 56

• IL-33/ST2 complex

  Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm

  At Baseline to week 56

• IL-33

  Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm

  At Baseline to week 56

• Air trapping index

  Measurement of lung structure profile and change through radiological parameters (CT scan)

  At Baseline to week 56

• hsCRP

  Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm

  At baseline to week 56

• Transcriptomic test in nasal, bronchial brushings, biopsies and BALF asmples

  Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm

  At baseline to week 56

• Proteomic test in blood, sputum, BALF and NLF samples

  Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm

  At baseline to week 56

Study Arms (5)

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.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a multi-center, longitudinal, observational study which includes COPD group with external healthy controls. External healthy controls will be selected from the healthy volunteers enrolled in the asthma translational study (D2287R00186, sponsored by AstraZeneca), whose characteristics match as the entry criteria for Cohort A in the study. Other than participating the procedures of asthma translational study with additional specific activities for COPD, no other activities will be performed in this COPD translational study for Cohort A.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

Beijing, China

RECRUITING

Research Site

Changsha, China

RECRUITING

Research Site

Chengdu, China

RECRUITING

Research Site

Guangzhou, China

RECRUITING

Research Site

Hefei, China

RECRUITING

Research Site

Nanjing, China

RECRUITING

Research Site

Nanning, China

RECRUITING

Research Site

Shanghai, China

RECRUITING

Research Site

Shanghai, China

NOT YET RECRUITING

Research Site

Shenyang, China

NOT YET RECRUITING

Research Site

Shenyang, China

RECRUITING

Research Site

Wuhan, China

RECRUITING

Research Site

Xuzhou, China

RECRUITING

Research Site

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: December 9, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): October 21, 2027
• Study Completion (Estimated): October 21, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CN (14)