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Clinical Trials in China / NCT07751003
Starting soon Not applicable

Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support

NCT07751003 · tracked via the Priya Life Science China tracker
Sponsor
Sir Run Run Shaw Hospital
Phase
Not applicable
Started
2027-08-01
Last updated
2026-08-06

Condition(s) studied

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)

FacilityCityRegionStatus
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 Wenling Zhejiang

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Official registry record

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.

View NCT07751003 on ClinicalTrials.gov ↗ ← All trials in China