An interventional study of Remote Management and Remote Monitoring Only in COPD (Chronic Obstructive Pulmonary Disease), Acute Exacerbation of COPD and Hypercapnia, sponsored by Sir Run Run Shaw Hospital. Not yet recruiting at 4 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Sir Run Run Shaw Hospital · Not applicable, Interventional, and Treatment
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.
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide. A subset of patients with severe COPD develops chronic hypercapnic respiratory failure, often requiring long-term home non-invasive ventilation (NIV). While NIV can improve gas exchange, optimal management strategies, particularly post-hospitalization, are still being investigated.
This study aims to determine if a proactive, remote management strategy can improve patient outcomes compared to standard care with passive monitoring.
Experimental Group (Remote Intervention): Participants will receive home NIV with remote monitoring. A respiratory therapist will actively review ventilation data, assess oxygenation, and perform remote parameter adjustments and individualized optimization based on pre-set conditions and risk predictions.
Control Group (Monitoring Control): Participants will receive home NIV with remote monitoring. However, the study team will not perform active interventions based on the monitoring data. Patients will continue with their usual care and follow-up with their primary physician. The study team will only make contact in case of a severe safety risk.
The study will enroll 236 participants who will be randomized 1:1 to one of the two groups. The primary outcomes are the change in health-related quality of life and the number of COPD exacerbations over 12 months.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 236 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Sir Run Run Shaw Hospital is the lead sponsor of 135 studies on the registry; 72 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive home non-invasive respiratory support combined with active remote management.
Other: Remote Management · Other: Remote Monitoring Only
Participants will receive home non-invasive respiratory support with remote monitoring only.
Other: Remote Monitoring Only
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.
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.
Change in Health-Related Quality of Life
Measured by the change from baseline in the total score of the St. George's Respiratory Questionnaire (SGRQ) questionnaire at 12 months.
Time frame: Baseline to 12 months
Number of COPD Exacerbations
The number of acute exacerbations requiring antibiotics and/or systemic corticosteroids within 12 months.
Time frame: 12 months
Change in PaCO₂
The change from baseline in arterial partial pressure of carbon dioxide (PaCO₂) at 1, 3, 6, and 12 months.
Time frame: Baseline, 1, 3, 6, 12 months
Changes in PaO₂
The change from baseline in arterial partial pressure of oxygen (PaO₂) at 1, 3, 6, and 12 months.
Time frame: Baseline, 1, 3, 6, 12 months
Change in Dyspnea Severity (mMRC Score)
The change from baseline in the modified Medical Research Council (mMRC) dyspnea scale score to each follow up. The scale ranges from 0 to 4, with higher scores indicating more severe dyspnea.
Time frame: Baseline, 1, 3, 6, 12 months
Change in CAT Score
The change from baseline in the total score of the COPD Assessment Test (CAT) at 1, 3, 6, and 12 months.
Time frame: Baseline, 1, 3, 6, and 12 months
Change in SRI Score
The change from baseline in the total score of the Severe Respiratory Insufficiency (SRI) questionnaire at 1, 3, 6, and 12 months.
Time frame: Time Frame: Baseline, 1, 3, 6, and 12 months
Average daily usage of Non-invasive Ventilation
Average daily usage of the non-invasive ventilation device (hours per day) recorded at 1, 3, 6, and 12 months.
Time frame: Baseline, 1, 3, 6, and 12 months
Adherence-Percentage of days with usage greater than 4 hours
Percentage of days with usage greater than 4 hours, recorded at 1, 3, 6, and 12 months.
Time frame: Baseline, 1, 3, 6, and 12 months
Adverse Events
The number and type of adverse events (AEs) and serious adverse events (SAEs) reported throughout the 12-month study duration.
Time frame: Baseline, 1, 3, 6, and 12 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →