Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study

NCT ID: NCT05681364

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2024-12-31

Brief Summary

To comprehensively evaluate the pulmonary rehabilitation (PR) outcomes of patients with chronic respiratory disease (CRD), and to screen biomarkers for predicting different PR outcomes of patients with CRD using metabolomics methods, and to build a prediction model.

Conditions

Chronic Obstructive Pulmonary Disease; Bronchiectasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD and bronchiectasis patients with some metabolic profiling

The patients with stable COPD and bronchiectasis who meet the screening criteria and with some metabolic profiling according to the previous studies.

metabonomics

Intervention Type: OTHER

profiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation

COPD and bronchiectasis patients without the metabolic profiling

The patients with stable COPD and bronchiectasis who meet the screening criteria and without the metabolic profiling according to the previous studies.

metabonomics

Intervention Type: OTHER

profiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation

Interventions

metabonomics

profiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• For COPD

1. Meets the Global initiative for chronic obstructive lung disease (GOLD) 2022 definition of stable COPD;

2. Age 30-75 years;

3. Lung CT images only showed chronic bronchitis and emphysema;

4. Agree to participate in the study and is able to cooperate with exhaled breath condensate collection.

• For bronchiectasis

1. Lung CT showed bronchiectasis;

2. Age 18-75 years;

3. Spirometry suggests obstructive ventilatory dysfunction: forced expiratory volume in one second (FEV1) is less than 70% of forced vital capacity (FVC) post bronchodilator inhalation.

Exclusion Criteria

1. Asthma or other respiratory diseases

2. History of pulmonary surgery

3. α1 antitrypsin deficiency

4. Autoimmune diseases

5. Patients with acute myocardial infarction, chronic heart failure, severe cerebral infarction or cerebral hemorrhage

6. A history of malignant disease now or within 2 years

7. History of acute exacerbation or change of medication in the past 4 weeks

8. A history of blood transfusion within the last 4 weeks

9. Drugs or alcohol abuse

10. Breastfeeding or pregnant women

11. Unable to cooperate with pulmonary rehabilitation for various reasons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fei Wang

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Central Contacts

Fei Wang, MD

Role: CONTACT

13671304203@139.com

0086 13671304203

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id