COPDHOPE-AERONCT06970054
Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study
A study testing OPEP and Aerobic Exercise in people with COPD and AECOPD, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the feasibility and effectiveness of home OPEP therapy and aerobic exercise training in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who are at high risk of acute exacerbations, aged 40-80 years. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- OPEP and Aerobic Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 40-80 years.
- Diagnosis of AECOPD according to 2025 GOLD criteria, GOLD stage 2-4.
- Patients seeking treatment for acute exacerbation of COPD (AECOPD) as outpatients or inpatients.
- Residing in the study center area with no plans to relocate during the study.
- Voluntary participation with signed informed consent.
Who cannot join
- Inability to walk or tolerate the 6-minute walk test.
- Inability to cooperate with lung function tests.
- Life expectancy <6 months (e.g., uncontrolled advanced malignancy, recent MI, unstable angina, acute stroke, acute heart failure).
- Active pulmonary tuberculosis or history of lung resection.
- Pregnancy or lactation.
- Liver or kidney failure requiring dialysis.
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- Participation in other drug clinical trials or interventional studies.
- Vulnerable populations (e.g., mental illness, cognitive impairment, critically ill, illiterate).
- Other reasons deemed unsuitable by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
About this study
Official title: Home Oscillatory Positive Expiratory Pressure Combined With Aerobic Exercise in Moderate to Severe COPD Patients: A Multicenter, Randomized Controlled Study
The goal of this clinical trial is to evaluate the feasibility and effectiveness of home OPEP therapy and aerobic exercise training in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who are at high risk of acute exacerbations, aged 40-80 years. The main questions it aims to answer are:
Does home OPEP therapy, aerobic exercise training, or the combination of both reduce the incidence and hospitalization rate of acute exacerbations of COPD compared to conventional treatment? What are the effects of these interventions on 6-minute walk distance, all-cause mortality, lung function, quality of life, and treatment adherence? Researchers will compare a) conventional treatment, b) OPEP therapy, c) aerobic exercise training, and d) OPEP therapy combined with aerobic exercise training to see if OPEP therapy and/or aerobic exercise training improve pulmonary rehabilitation outcomes.
Read more
Participants will:
Receive assigned intervention based on the study arm (conventional treatment, OPEP therapy, aerobic exercise, or combined therapy).
Use respiratory training devices and/or wearable monitoring devices as required by their assigned group.
Follow training plans and therapy schedules. Attend follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months.
Complete questionnaires and undergo assessments (e.g., lung function tests, 6-minute walk tests) at baseline and follow-up visits.
- Being tested
- OPEP, Aerobic Exercise
- Keywords
- Oscillating Positive Expiratory Pressure, OPEP, COPD, AECOPD, Chronic Obstructive Pulmonary Disease, Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Airway Clearance, Global Initiative for Chronic Obstructive Lung Disease, GOLD, aerobic exercise, cardio, COPD management, Internet of Things, IoT
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPEPDevice
-Patients are provided with a networked handheld respiratory training device. -Patients are provided with a wearable device for monitoring data. -Patients receive an OPEP training plan and instructions on using the respiratory training device. -Training on the OPEP device is conducted: -Inpatients: Twice daily training during hospitalization. -Outpatients: At least 3 training sessions in the clinic after enrollment. -Treatment compliance is monitored remotely via the IoT system for 8 weeks. -Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit).
Aerobic ExerciseBehavioural
-Patients are provided with a wearable device for monitoring data. -Patients receive an aerobic exercise training plan and instructions on using the device. -Exercise training is conducted: -Inpatients: Daily aerobic exercise during hospitalization. -Outpatients: At least 3 training sessions in the clinic after enrollment. -Treatment compliance is monitored remotely via the IoT system for 8 weeks. -Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit).
| Study group | Role | What they receive |
|---|---|---|
| OPEP only | Experimental | * Patients are provided with an internet-connected handheld respiratory training device.
* Patients are provided with a wearable device for monitoring data.
* Patients receive an OPEP training plan and instructions on using the respiratory training device.
* Training on the OPEP device is conducted:
* Inpatients: Twice daily training during hospitalization.
* Outpatients: At least 3 training sessions in the clinic after enrollment.
* Treatment compliance is monitored remotely via the IoT system for 8 weeks.
* Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). Receives: Device: OPEP |
| Aerobic Exercise Group | Experimental | * Patients are provided with a wearable device for monitoring data.
* Patients receive an aerobic exercise training plan and instructions on using the device.
* Exercise training is conducted:
* Inpatients: Daily aerobic exercise during hospitalization.
* Outpatients: At least 3 training sessions in the clinic after enrollment.
* Treatment compliance is monitored remotely via the IoT system for 8 weeks.
* Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). Receives: Behavioral: Aerobic Exercise |
| OPEP and Aerobic Exercise | Experimental | * Patients receive both an internet-connected handheld respiratory training device and a wearable device.
* Patients receive OPEP and aerobic exercise training plans and instructions.
* Training is conducted:
* Inpatients: Twice daily OPEP training and daily aerobic exercise during hospitalization.
* Outpatients: At least 3 training sessions in the clinic after enrollment.
* Treatment compliance is monitored remotely via the IoT system for 8 weeks.
* Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). Receives: Device: OPEP; Behavioral: Aerobic Exercise |
| Control | No intervention | * Patients are advised to maintain their usual activity levels. * Patients continue with their prescribed medications. * Patients receive routine management, including outpatient education. * No specific interventions like respiratory training devices or structured exercise programs are provided. * Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AECOPD
Incidence of moderate to severe acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD). Acute exacerbation of COPD is defined according to the Chinese expert consensus on diagnosis and treatment of acute exacerbation of chronic obstructive pulmonary disease (revised edition 2023)
Measured: Over the 24-month follow-up period
Hospitalization Rates of AECOPD
Hospitalization rate of moderate to severe acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD). Acute exacerbation of COPD is defined according to the Chinese expert consensus on diagnosis and treatment of acute exacerbation of chronic obstructive pulmonary disease (revised edition 2023)
Measured: Over the 24-month follow-up period
Secondary outcomes (20)
6-Minute Walk Distance
Measures the distance a participant can walk in six minutes as an indicator of functional exercise capacity. Higher is better.
Measured: 1, 2, 6, 12, 24 months, and over 24 months
All-Cause Mortality
Measured: 24 months
Number of Acute Exacerbations
Total count of acute exacerbation events experienced by each participant.
Measured: 1, 2, 6, 12, 24 months, and over 24 months
Proportion of Participants with ≥2 Acute Exacerbations
Percentage of participants experiencing two or more acute exacerbations within 24 months.
Measured: 24 months
Time to First Acute Exacerbation
Duration from study start to the first recorded acute exacerbation for each participant.
Measured: 24 months
COPD Assessment Test (CAT) Score
Self-reported measure of health status in COPD patients, assessed using the CAT questionnaire. Higher scores indicate a greater impact of COPD on a patient's daily life.
Measured: 1, 2, 6, 12, and 24 months
Modified Medical Research Council (mMRC) Dyspnea Score
Patient-rated scale assessing the severity of breathlessness. Higher grade indicates higher severity.
Measured: 1, 2, 6, 12, and 24 months
St. George's Respiratory Questionnaire (SGRQ) Score
Quality of life assessment specific to respiratory diseases. Higher scores reflect worse health-related quality of life.
Measured: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameter-FVC
Forced Vital Capacity (FVC) measured in Liters
Measured: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameter-FEV1
Forced Expiratory Volume in 1 Second (FEV1) measured in Liters
Measured: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameters - FEV1 predicted
Predicted Forced Expiratory Volume in 1 second (FEV1 predicted) measured in percentage, calculated using GLI-asian equation
Measured: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameters - FEV1/FVC ratio
Forced Expiratory Volume in the first second to Forced Vital Capacity (FEV1/FVC ratio), percentage.
Measured: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameters - PEF
Peak Expiratory Flow (PEF) measured in L/min
Measured: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameters - MMEF
Maximum Mid-Expiratory Flow (MMEF) percentage of predicted normal
Measured: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - pH
In arterial blood gas test, pH is a measurement of the acid-base balance of the blood. A normal blood pH range is between 7.35 and 7.45. A pH below 7.35 indicates acidosis, while a pH above 7.45 indicates alkalosis. pH has no units.
Measured: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - PaO2
Partial pressure of oxygen (PaO2), in blood gas analysis measures the amount of dissolved oxygen in arterial blood. It's an indicator of oxygenation and is measured in millimeters of mercury (mmHg). A normal PaO2 range is 80-100 mmHg.
Measured: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - PaCO2
Partial pressure of carbon dioxide (PaCO2), is a measure of the amount of dissolved carbon dioxide in arterial blood. It's a key indicator of ventilation status, essentially reflecting how well the lungs are removing CO2. It is measured in millimeter mercury (mmHg) and a normal PaCO2 range is 35-45 mmHg.
Measured: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - PaO2/FiO2
PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
Measured: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - HCO3
HCO3 refers to the bicarbonate level in the blood, which is a crucial component of acid-base balance. A normal HCO3 range on an ABG is typically between 22 and 26 mEq/L.
Measured: 1, 2, 6, 12, and 24 months
Treatment Compliance
Evaluation of participants' adherence to prescribed treatments and protocols throughout the study using device data and aerobic exercise records.
Measured: 1, 2, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start20 Mar 2026
- Primary completionMay 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- 312 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
- Investigators
- Huiqing Ge, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970054
- Sponsor's protocol ID
- 20250243
- Acronym
- HOPE-AERO
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bishop JA, Spencer LM, Dwyer TJ, McKeough ZJ, McAnulty A, Alison JA. Changes in Exercise Capacity and Health-Related Quality of Life at Four and Eight Weeks of a Pulmonary Rehabilitation Program in People with COPD. COPD. 2021 Dec;18(6):612-620. doi: 10.1080/15412555.2021.2013793. Epub 2021 Dec 19.
PubMed 34927525Meghji J, Mortimer K, Agusti A, Allwood BW, Asher I, Bateman ED, Bissell K, Bolton CE, Bush A, Celli B, Chiang CY, Cruz AA, Dinh-Xuan AT, El Sony A, Fong KM, Fujiwara PI, Gaga M, Garcia-Marcos L, Halpin DMG, Hurst JR, Jayasooriya S, Kumar A, Lopez-Varela MV, Masekela R, Mbatchou Ngahane BH, Montes de Oca M, Pearce N, Reddel HK, Salvi S, Singh SJ, Varghese C, Vogelmeier CF, Walker P, Zar HJ, Marks GB. Improving lung health in low-income and middle-income countries: from challenges to solutions. Lancet. 2021 Mar 6;397(10277):928-940. doi: 10.1016/S0140-6736(21)00458-X. Epub 2021 Feb 22.
PubMed 33631128Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
PubMed 31248666Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
PubMed 29650248Celli B, Fabbri L, Criner G, Martinez FJ, Mannino D, Vogelmeier C, Montes de Oca M, Papi A, Sin DD, Han MK, Agusti A. Definition and Nomenclature of Chronic Obstructive Pulmonary Disease: Time for Its Revision. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1317-1325. doi: 10.1164/rccm.202204-0671PP. No abstract available.
PubMed 35914087
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Oscillatory Positive Expiratory Pressure Combined With Aerobic Exercise in Moderate to Severe COPD Patients: A Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06970054
- Acronym / sponsor ID
- HOPE-AERO / 20250243
- Keywords
- Oscillating Positive Expiratory Pressure, OPEP, COPD, AECOPD, Chronic Obstructive Pulmonary Disease, Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Airway Clearance, Global Initiative for Chronic Obstructive Lung Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the feasibility and effectiveness of home OPEP therapy and aerobic exercise training in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who are at high risk of acute exacerbations, aged 40-80 years. The main questions it aims to answer are:
Does home OPEP therapy, aerobic exercise training, or the combination of both reduce the incidence and hospitalization rate of acute exacerbations of COPD compared to conventional treatment? What are the effects of these interventions on 6-minute walk distance, all-cause mortality, lung function, quality of life, and treatment adherence? Researchers will compare a) conventional treatment, b) OPEP therapy, c) aerobic exercise training, and d) OPEP therapy combined with aerobic exercise training to see if OPEP therapy and/or aerobic exercise training improve pulmonary rehabilitation outcomes.
Participants will:
Receive assigned intervention based on the study arm (conventional treatment, OPEP therapy, aerobic exercise, or combined therapy).
Use respiratory training devices and/or wearable monitoring devices as required by their assigned group.
Follow training plans and therapy schedules. Attend follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months.
Complete questionnaires and undergo assessments (e.g., lung function tests, 6-minute walk tests) at baseline and follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OPEP only | Experimental | Device: OPEP* Patients are provided with an internet-connected handheld respiratory training device. * Patients are provided with a wearable device for monitoring data. * Patients receive an OPEP training plan and instructions on using the respiratory training device. * Training on the OPEP device is conducted: * Inpatients: Twice daily training during hospitalization. * Outpatients: At least 3 training sessions in the clinic after enrollment. * Treatment compliance is monitored remotely via the IoT system for 8 weeks. * Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). |
| Aerobic Exercise Group | Experimental | Behavioral: Aerobic Exercise* Patients are provided with a wearable device for monitoring data. * Patients receive an aerobic exercise training plan and instructions on using the device. * Exercise training is conducted: * Inpatients: Daily aerobic exercise during hospitalization. * Outpatients: At least 3 training sessions in the clinic after enrollment. * Treatment compliance is monitored remotely via the IoT system for 8 weeks. * Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). |
| OPEP and Aerobic Exercise | Experimental | Device: OPEP, Behavioral: Aerobic Exercise* Patients receive both an internet-connected handheld respiratory training device and a wearable device. * Patients receive OPEP and aerobic exercise training plans and instructions. * Training is conducted: * Inpatients: Twice daily OPEP training and daily aerobic exercise during hospitalization. * Outpatients: At least 3 training sessions in the clinic after enrollment. * Treatment compliance is monitored remotely via the IoT system for 8 weeks. * Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). |
| Control | No intervention | –* Patients are advised to maintain their usual activity levels. * Patients continue with their prescribed medications. * Patients receive routine management, including outpatient education. * No specific interventions like respiratory training devices or structured exercise programs are provided. * Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-80 years.
- Diagnosis of AECOPD according to 2025 GOLD criteria, GOLD stage 2-4.
- Patients seeking treatment for acute exacerbation of COPD (AECOPD) as outpatients or inpatients.
- Residing in the study center area with no plans to relocate during the study.
- Voluntary participation with signed informed consent.
Key exclusion criteria (9 listed)
- Inability to walk or tolerate the 6-minute walk test.
- Inability to cooperate with lung function tests.
- Life expectancy <6 months (e.g., uncontrolled advanced malignancy, recent MI, unstable angina, acute stroke, acute heart failure).
- Active pulmonary tuberculosis or history of lung resection.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPEP-Patients are provided with a networked handheld respiratory training device. -Patients are provided with a wearable device for monitoring data. -Patients receive an OPEP training plan and instructions on using the respiratory training device. -Training on the OPEP device is conducted: -Inpatients: Twice daily training during hospitalization. -Outpatients: At least 3 training sessions in the clinic after enrollment. -Treatment compliance is monitored remotely via the IoT system for 8 weeks. -Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). | Device | OPEP and Aerobic Exercise, OPEP only |
| Aerobic Exercise-Patients are provided with a wearable device for monitoring data. -Patients receive an aerobic exercise training plan and instructions on using the device. -Exercise training is conducted: -Inpatients: Daily aerobic exercise during hospitalization. -Outpatients: At least 3 training sessions in the clinic after enrollment. -Treatment compliance is monitored remotely via the IoT system for 8 weeks. -Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit). | Behavioural | Aerobic Exercise Group, OPEP and Aerobic Exercise |
Primary outcome
Incidence of AECOPD
Time frame: Over the 24-month follow-up period
Incidence of moderate to severe acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD). Acute exacerbation of COPD is defined according to the Chinese expert consensus on diagnosis and treatment of acute exacerbation of chronic obstructive pulmonary disease (revised edition 2023)
Hospitalization Rates of AECOPD
Time frame: Over the 24-month follow-up period
Hospitalization rate of moderate to severe acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD). Acute exacerbation of COPD is defined according to the Chinese expert consensus on diagnosis and treatment of acute exacerbation of chronic obstructive pulmonary disease (revised edition 2023)
20 secondary outcomes
6-Minute Walk Distance
Time frame: 1, 2, 6, 12, 24 months, and over 24 months
All-Cause Mortality
Time frame: 24 months
Number of Acute Exacerbations
Time frame: 1, 2, 6, 12, 24 months, and over 24 months
Proportion of Participants with ≥2 Acute Exacerbations
Time frame: 24 months
Time to First Acute Exacerbation
Time frame: 24 months
COPD Assessment Test (CAT) Score
Time frame: 1, 2, 6, 12, and 24 months
Modified Medical Research Council (mMRC) Dyspnea Score
Time frame: 1, 2, 6, 12, and 24 months
St. George's Respiratory Questionnaire (SGRQ) Score
Time frame: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameter-FVC
Time frame: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameter-FEV1
Time frame: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameters - FEV1 predicted
Time frame: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameters - FEV1/FVC ratio
Time frame: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameters - PEF
Time frame: 1, 2, 6, 12, and 24 months
Changes in Lung Function Parameters - MMEF
Time frame: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - pH
Time frame: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - PaO2
Time frame: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - PaCO2
Time frame: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - PaO2/FiO2
Time frame: 1, 2, 6, 12, and 24 months
Changes in Blood Gas Parameters - HCO3
Time frame: 1, 2, 6, 12, and 24 months
Treatment Compliance
Time frame: 1, 2, 6, 12, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 34927525Bishop JA, Spencer LM, Dwyer TJ, McKeough ZJ, McAnulty A, Alison JA. Changes in Exercise Capacity and Health-Related Quality of Life at Four and Eight Weeks of a Pulmonary Rehabilitation Program in People with COPD. COPD. 2021 Dec;18(6):612-620. doi: 10.1080/15412555.2021.2013793. Epub 2021 Dec 19.
- Background: PubMed 33631128Meghji J, Mortimer K, Agusti A, Allwood BW, Asher I, Bateman ED, Bissell K, Bolton CE, Bush A, Celli B, Chiang CY, Cruz AA, Dinh-Xuan AT, El Sony A, Fong KM, Fujiwara PI, Gaga M, Garcia-Marcos L, Halpin DMG, Hurst JR, Jayasooriya S, Kumar A, Lopez-Varela MV, Masekela R, Mbatchou Ngahane BH, Montes de Oca M, Pearce N, Reddel HK, Salvi S, Singh SJ, Varghese C, Vogelmeier CF, Walker P, Zar HJ, Marks GB. Improving lung health in low-income and middle-income countries: from challenges to solutions. Lancet. 2021 Mar 6;397(10277):928-940. doi: 10.1016/S0140-6736(21)00458-X. Epub 2021 Feb 22.
- Background: PubMed 31248666Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
- Background: PubMed 29650248Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
- Background: PubMed 35914087Celli B, Fabbri L, Criner G, Martinez FJ, Mannino D, Vogelmeier C, Montes de Oca M, Papi A, Sin DD, Han MK, Agusti A. Definition and Nomenclature of Chronic Obstructive Pulmonary Disease: Time for Its Revision. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1317-1325. doi: 10.1164/rccm.202204-0671PP. No abstract available.
- Global initiative for chronic obstructive lung disease.Global strategy for prevention,diagnosis and management of COPD: 2024 ReportLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiqing Ge, MD principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPEP and Aerobic Exercise in people with COPD and AECOPD, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AECOPD (time frame: Over the 24-month follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06970054, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.