Chronic Obstructive Pulmonary DiseaseNCT04843696
Negative Pressure Ventilation-rehabilitation on Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy) and breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) in people with Chronic Obstructive Pulmonary Disease and Acute Exacerbation of COPD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This investigator-initiated, prospective, single center, randomized, controlled clinical trial enrolled patients with stable Global Initiative for Chronic Obstructive Lung Disease stage II-IV chronic obstruction pulmonary disease. The primary outcome was 2-year acute exacerbation rates. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation of COPD
- What is being tested?
- cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy) and breathing training, and an educational program (relaxation techniques and a home pacing walking exercise)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD ((post-bronchodilation forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) <0.7)
- Optimal medical treatment according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)) at least 3 months before screening
Who cannot join
- abnormalities of the thorax or the lung other than COPD,
- acute exacerbation within one month
- obesity with a body-mass index (BMI) ≥35 kg/m²,
- malignant co-morbidities, severe heart failure (New York Heart Association stage IV), unstable angina, severe arrhythmias, neuromuscular diseases and/or impairment of basal brain nerve function with disturbed swallowing and choking and impaired general condition that could preclude regular follow-up visits.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Hung Yu Huang, + 886 33281200 ext. 8470, b9202071@cgmh.org.tw
About this study
Official title: Negative Pressure Ventilation-rehabilitation on Acute Exacerbation and Associated Molecular Biomarkers and Cytokines in Chronic Obstructive Pulmonary Disease Over 2 Years
This investigator-initiated, prospective, single center, randomized, controlled clinical trial enrolled patients with stable Global Initiative for Chronic Obstructive Lung Disease stage II-IV chronic obstruction pulmonary disease. The primary outcome was 2-year acute exacerbation rates.
Read the detailed description
Pulmonary rehabilitation (PR) has been suggested to be positive effects on 6 min walking distance (6MWD), muscle force, cycle exercise endurance time, and quality of life. However, the literature still could not explain the role of PR in reducing systemic inflammation of chronic obstruction pulmonary disease (COPD) patients. A recent study found that PR with negative pressure ventilation (NPV) improved lung function, exercise capacity and reduced acute exacerbation rates in COPD patients. The objectives of this research are to design a prospective, randomized controlled trial to determine the clinical outcome of NPV-PR in COPD patients and to investigate if NPV-PR reduces systemic inflammation in patients with COPD.
This investigator-initiated, prospective, single center, randomized, controlled clinical trial enrolled patients with stable Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV COPD. NPV was targeted to reduce baseline blood carbon dioxide by at least 20% during NPV titration. Patients were randomly assigned (in a 1:1 ratio) to continue optimised standard treatment (control group) or to receive additional NPV-PR for at least 24 months (intervention group). The primary outcome was 2-year acute exacerbation rates. The lung function and walking distance will be assessed by six-minute walking tests and the severity of disease will be evaluated by high resolution computed tomography scores. Peripheral blood sample will be collected to analyze the inflammatory cytokines and oxidative markers.
In the present prospective study, investigators hypothesize that NPV-PR would be superior to usual care in reducing the risk for acute exacerbations of COPD, hospitalisations and emergency visits over a 24-month period. This research will provide evidence for the role of NPV-PR in the management of COPD, and evidence for a role of systemic inflammation in disease progression of COPD. The results may provide certain insights into more effective treatments to inhibit the disease progression of COPD.
- Being tested
- cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy), breathing training, and an educational program (relaxation techniques and a home pacing walking exercise)
- Keywords
- Chronic obstructive pulmonary disease, Negative-pressure ventilation, Acute Exacerbation
- 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.
cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy)Device
the hospital-based NPV once per week in the maintenance program at least three times per month. The ventilator is set to the control model with a frequency of 12~15 cycles/min, 30% of the ratio of inspiratory time to total breathing cycle time (Ti/Ttot), and delivery of negative pressures ranging from -20 to -35 cm H2O.
breathing training, and an educational program (relaxation techniques and a home pacing walking exercise)Behavioural
breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing)
| Study group | Role | What they receive |
|---|---|---|
| NPV group | Experimental | The hospital-based maintenance NPV program includes NPV support, breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) in daily clinical practice. The patients in the NPV group undergo the hospital-based NPV once per week in the maintenance program at least three times per month.
The patients received NPV with breathing training via a cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy) for 60 min, once per week.
Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing). Receives: Device: cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy); Behavioral: breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) |
| Control group | Active comparator | Control group receives breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) in daily clinical practice.
Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing). Receives: Behavioral: breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD acute exacerbations rate
mild (required treatment with oral/systemic corticosteroids and/or antibiotics, without hospitalization) moderate (required treatment with oral/systemic corticosteroids and/or antibiotics, with emergency department visits) severe (required in-patient hospitalization)
Measured: 2 years
Secondary outcomes (3)
the yearly rate of decline of forced expiratory volume in 1 second (FEV1)
the yearly rate of decline of FEV1
Measured: 2 years
the yearly rate of decline of 6 minute walking distance (6MWD)
the yearly rate of decline of 6MWD
Measured: 2 years
Mortality
overall and pulmonary related
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start8 Apr 2021
- Primary completion10 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843696
- Sponsor's protocol ID
- 201902168B0
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IRB of Chang Gung Memorial Hospital does not permit to share IPD in this project.
Publications
Huang HY, Lo CY, Yang LY, Chung FT, Sheng TF, Lin HC, Lin CW, Huang YC, Chang CJ, Chung KF, Wang CH. Maintenance Negative Pressure Ventilation Improves Survival in COPD Patients with Exercise Desaturation. J Clin Med. 2019 Apr 25;8(4):562. doi: 10.3390/jcm8040562.
PubMed 31027263Huang HY, Chou PC, Joa WC, Chen LF, Sheng TF, Lin HC, Yang LY, Pan YB, Chung FT, Wang CH, Kuo HP. Pulmonary rehabilitation coupled with negative pressure ventilation decreases decline in lung function, hospitalizations, and medical cost in COPD: A 5-year study. Medicine (Baltimore). 2016 Oct;95(41):e5119. doi: 10.1097/MD.0000000000005119.
PubMed 27741132
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Ventilation-rehabilitation on Acute Exacerbation and Associated Molecular Biomarkers and Cytokines in Chronic Obstructive Pulmonary Disease Over 2 Years
- ClinicalTrials.gov ID
- NCT04843696
- Acronym / sponsor ID
- 201902168B0
- Keywords
- Chronic obstructive pulmonary disease, Negative-pressure ventilation, Acute Exacerbation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 10 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Apr 2021 (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.
This investigator-initiated, prospective, single center, randomized, controlled clinical trial enrolled patients with stable Global Initiative for Chronic Obstructive Lung Disease stage II-IV chronic obstruction pulmonary disease. The primary outcome was 2-year acute exacerbation rates.
Detailed description
Pulmonary rehabilitation (PR) has been suggested to be positive effects on 6 min walking distance (6MWD), muscle force, cycle exercise endurance time, and quality of life. However, the literature still could not explain the role of PR in reducing systemic inflammation of chronic obstruction pulmonary disease (COPD) patients. A recent study found that PR with negative pressure ventilation (NPV) improved lung function, exercise capacity and reduced acute exacerbation rates in COPD patients. The objectives of this research are to design a prospective, randomized controlled trial to determine the clinical outcome of NPV-PR in COPD patients and to investigate if NPV-PR reduces systemic inflammation in patients with COPD.
This investigator-initiated, prospective, single center, randomized, controlled clinical trial enrolled patients with stable Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV COPD. NPV was targeted to reduce baseline blood carbon dioxide by at least 20% during NPV titration. Patients were randomly assigned (in a 1:1 ratio) to continue optimised standard treatment (control group) or to receive additional NPV-PR for at least 24 months (intervention group). The primary outcome was 2-year acute exacerbation rates. The lung function and walking distance will be assessed by six-minute walking tests and the severity of disease will be evaluated by high resolution computed tomography scores. Peripheral blood sample will be collected to analyze the inflammatory cytokines and oxidative markers.
In the present prospective study, investigators hypothesize that NPV-PR would be superior to usual care in reducing the risk for acute exacerbations of COPD, hospitalisations and emergency visits over a 24-month period. This research will provide evidence for the role of NPV-PR in the management of COPD, and evidence for a role of systemic inflammation in disease progression of COPD. The results may provide certain insights into more effective treatments to inhibit the disease progression of COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPV group | Experimental | Device: cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy), Behavioral: breathing training, and an educational program (relaxation techniques and a home pacing walking exercise)The hospital-based maintenance NPV program includes NPV support, breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) in daily clinical practice. The patients in the NPV group undergo the hospital-based NPV once per week in the maintenance program at least three times per month. The patients received NPV with breathing training via a cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy) for 60 min, once per week. Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing). |
| Control group | Active comparator | Behavioral: breathing training, and an educational program (relaxation techniques and a home pacing walking exercise)Control group receives breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) in daily clinical practice. Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of COPD ((post-bronchodilation forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) <0.7)
- Optimal medical treatment according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)) at least 3 months before screening
Key exclusion criteria (4 listed)
- abnormalities of the thorax or the lung other than COPD,
- acute exacerbation within one month
- obesity with a body-mass index (BMI) ≥35 kg/m²,
- malignant co-morbidities, severe heart failure (New York Heart Association stage IV), unstable angina, severe arrhythmias, neuromuscular diseases and/or impairment of basal brain nerve function with disturbed swallowing and choking and impaired general condition that could preclude regular follow-up visits.
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 |
|---|---|---|
| cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy)the hospital-based NPV once per week in the maintenance program at least three times per month. The ventilator is set to the control model with a frequency of 12~15 cycles/min, 30% of the ratio of inspiratory time to total breathing cycle time (Ti/Ttot), and delivery of negative pressures ranging from -20 to -35 cm H2O. | Device | NPV group |
| breathing training, and an educational program (relaxation techniques and a home pacing walking exercise)breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing) | Behavioural | Control group, NPV group |
Primary outcome
COPD acute exacerbations rate
Time frame: 2 years
mild (required treatment with oral/systemic corticosteroids and/or antibiotics, without hospitalization) moderate (required treatment with oral/systemic corticosteroids and/or antibiotics, with emergency department visits) severe (required in-patient hospitalization)
3 secondary outcomes
the yearly rate of decline of forced expiratory volume in 1 second (FEV1)
Time frame: 2 years
the yearly rate of decline of 6 minute walking distance (6MWD)
Time frame: 2 years
Mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Background: PubMed 31027263Huang HY, Lo CY, Yang LY, Chung FT, Sheng TF, Lin HC, Lin CW, Huang YC, Chang CJ, Chung KF, Wang CH. Maintenance Negative Pressure Ventilation Improves Survival in COPD Patients with Exercise Desaturation. J Clin Med. 2019 Apr 25;8(4):562. doi: 10.3390/jcm8040562.
- Background: PubMed 27741132Huang HY, Chou PC, Joa WC, Chen LF, Sheng TF, Lin HC, Yang LY, Pan YB, Chung FT, Wang CH, Kuo HP. Pulmonary rehabilitation coupled with negative pressure ventilation decreases decline in lung function, hospitalizations, and medical cost in COPD: A 5-year study. Medicine (Baltimore). 2016 Oct;95(41):e5119. doi: 10.1097/MD.0000000000005119.
- Individual participant dataSharing planned: No. The IRB of Chang Gung Memorial Hospital does not permit to share IPD in this project.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy) and breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) in people with Chronic Obstructive Pulmonary Disease and Acute Exacerbation of COPD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung Yu Huang (+ 886 33281200 ext. 8470, b9202071@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD acute exacerbations rate (time frame: 2 years). 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 NCT04843696, which also lists 2 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 13 Apr 2021.