COPD (Chronic Obstructive Pulmonary Disease)NCT07751003
Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support
A study testing Remote Management and Remote Monitoring Only in people with COPD (Chronic Obstructive Pulmonary Disease) and Acute Exacerbation of COPD, run by Sir Run Run Shaw Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Acute Exacerbation of COPD, Hypercapnia
- What is being tested?
- Remote Management and Remote Monitoring Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 4 sitesChina
- Study dates
- 1 Aug 2027to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410006
Liucun Li, +86 0731-852959999, xyeyyibd@sina.com
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
Huiqing Ge, +86 13588706787, gehq@zju.edu.cn
Taizhou Hospital of Integrated Traditional Chinese and Western Medicine
Wenling, Zhejiang, 317523
Ting Jiang, +86 13758692956, 13758692956@139.com
Henan Provincial People's Hospital
Zhengzhou, Henan
Qiang Kui, MD, +86 13460317523, syhxzzggyx@163.com
About this study
Official title: A Randomized Controlled Trial of Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support
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.
Read the detailed description
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.
- Being tested
- Remote Management, Remote Monitoring Only
- Keywords
- Home management, Telehealth
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ManagementOther
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 OnlyOther
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 group | Role | What they receive |
|---|---|---|
| Remote Intervention Group | Experimental | Participants will receive home non-invasive respiratory support combined with active remote management. Receives: Other: Remote Management; Other: Remote Monitoring Only |
| Monitoring Control Group | Active comparator | Participants will receive home non-invasive respiratory support with remote monitoring only. Receives: Other: Remote Monitoring Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Number of COPD Exacerbations
The number of acute exacerbations requiring antibiotics and/or systemic corticosteroids within 12 months.
Measured: 12 months
Secondary outcomes (8)
Change in PaCO₂
The change from baseline in arterial partial pressure of carbon dioxide (PaCO₂) at 1, 3, 6, and 12 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Aug 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqing Ge, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751003
- Sponsor's protocol ID
- 20260597
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided