COPD (Chronic Obstructive Pulmonary Disease)Acute Exacerbation of COPDHypercapnia
Investigational drug(s) / intervention(s)
Remote ManagementRemote Monitoring Only
Remote Management: Participants will receive home non-invasive respiratory support combined with active remote management. This includes regular analysis of ventilation data, assessment of oxygenation status, risk prediction, and remote parameter adjustment by a respiratory therapist.
Remote Monitoring Only: Participants will receive home non-invasive respiratory support with remote monitoring only. No active intervention will be performed by the study team based on the data. Patients will continue with standard care from their primary physician.
Study summary
This study is a randomized controlled trial designed to compare the effectiveness of active remote intervention versus passive monitoring alone in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic hypercapnic respiratory failure who are receiving home non-invasive respiratory support. The primary goal is to evaluate the impact on health-related quality of life and the frequency of acute exacerbations over a 12-month period.
Eligibility
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Meets the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD) with confirmed persistent airflow limitation by spirometry.
* Hospitalized due to an acute exacerbation of COPD.
* Stable daytime arterial blood gas analysis showing PaCO₂ ≥ 50 mmHg, with hypoxemia.
* Already receiving or planned to receive long-term home non-invasive respiratory support.
* Capable of using a smartphone or tablet for video communication and has internet access.
* Willing to participate and provides written informed consent.
Exclusion Criteria:
* Concurrent severe pulmonary diseases (e.g., active tuberculosis, diffuse pulmonary fibrosis, advanced lung cancer).
* Chronic respiratory failure primarily caused by non-COPD conditions (e.g., neuromuscular disease, chest wall deformity, or severe obesity hypoventilation syndrome).
* Severe cognitive impairment or psychiatric illness that would prevent cooperation with remote management.
* Other severe systemic diseases with an expected survival of less than 1 year (e.g., advanced malignancy).
* Pregnant or lactating women.
Primary outcome measure(s)
Change in Health-Related Quality of Life — Baseline to 12 months Measured by the change from baseline in the total score of the St. George's Respiratory Questionnaire (SGRQ) questionnaire at 12 months.
Number of COPD Exacerbations — 12 months The number of acute exacerbations requiring antibiotics and/or systemic corticosteroids within 12 months.
Trial sites (4)
Facility
City
Region
Status
Henan Provincial People's Hospital
Zhengzhou
Henan
The Second Xiangya Hospital of Central South University
Changsha
Hunan
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
Taizhou Hospital of Integrated Traditional Chinese and Western Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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