Clinical trial NCT06724848: A Translational Study for Prediction of Biomarkers and Identification of Phenotype and Endotype of COPD and Early COPD Outcomes in Chinese Population
Official title: A Translational Study in Patients With COPD and Early 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 850
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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. External healthy controls are asymptomatic non-smokers, and do not have significant other exposures such as biomass, air pollution, and occupational.

Brief summary: 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.


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 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.

Primary outcomes:
measure: Medical History
timeFrame: At Baseline
measure: Occupation
timeFrame: At Baseline
measure: Birth Status
timeFrame: At Baseline
measure: Place of residence
timeFrame: At Baseline
measure: Smoking history and status
timeFrame: At Baseline to week 56
measure: Family history
timeFrame: At Baseline
measure: Exacerbation/respiratory history and event
timeFrame: At Baseline
measure: COPD related HRU
timeFrame: At Baseline
measure: SGRQ
timeFrame: At Baseline to week 56
measure: CAT
timeFrame: At Baseline to week 56
measure: MARS-5 (only applicable for COPD cohort)
timeFrame: At Baseline to week 56
measure: Variables in COPD related medication, changes in medication
timeFrame: At Baseline to week 56
measure: FEV1 %
timeFrame: At Baseline to week 56
measure: FEV1 /FVC
timeFrame: At Baseline to week 56
measure: Forced Osc
timeFrame: At Baseline to week 56
measure: FEF25-75
timeFrame: At Baseline to week 56
measure: DLCO
timeFrame: At Baseline to week 56
measure: Air trapping (E/I ratio)
timeFrame: At Baseline to week 56
measure: Ratio of airway thickness to outer diameter (T/D ratio)
timeFrame: At Baseline to week 56
measure: WA%
timeFrame: At Baseline to week 56
measure: Inflammatory differentials and counts in blood and BALF
timeFrame: At Baseline to week 56
measure: Inflammatory cell infiltration
timeFrame: At Baseline to week 56
measure: Pathological airway remodeling through IHC on biopsies
timeFrame: At Baseline to week 56
measure: MUC5AC
timeFrame: At Baseline to week 56
measure: sST2
timeFrame: At Baseline to week 56
measure: EPO
timeFrame: At Baseline to week 56
measure: Isoprostanes (IsoPs)
timeFrame: At Baseline to week 56
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xuzhou
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
Study officials:
References: