COPDCOPDNCT07777497
Respiratory Therapist-Supported Home Noninvasive Ventilation in Stable Severe COPD Without Hypercapnia
A study testing BreathePal Bilevel Positive Pressure System (GFM50-MD2201) in people with COPD, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Chronic obstructive pulmonary disease (COPD) can cause persistent breathing problems, reduced exercise capacity, and repeated worsening of symptoms. Noninvasive ventilation (NIV) provides breathing support through a mask. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- BreathePal Bilevel Positive Pressure System (GFM50-MD2201)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jan 2024to 31 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged 20 years or older.
- Diagnosis of severe chronic obstructive pulmonary disease (COPD).
- Post-bronchodilator FEV1/FVC < 0.70.
- FEV1 < 50% of the predicted value with at least one moderate or severe COPD exacerbation in the previous year; or FEV1 50%-80% of the predicted value with at least two moderate exacerbations or at least one severe exacerbation in the previous year.
- Able to breathe spontaneously and not dependent on continuous bilevel positive airway pressure ventilation for life support.
- No acute myocardial infarction or life-threatening cardiac arrhythmia.
- No acute facial injury.
- No indication for an artificial airway for conditions such as secretion clearance or upper airway obstruction.
Who cannot join
- Pregnancy or suspected pregnancy.
- Hemodynamic instability.
- Recent facial surgery.
- Excessive or excessively thick respiratory secretions.
- Sleep apnea.
- Other causes of chronic airway obstruction, such as bronchiectasis.
- Significant comorbid disease, such as left ventricular failure.
- Contraindications to noninvasive positive-pressure ventilation, including acute sinusitis, otitis media, pneumothorax, pathological hypotension, dehydration, cerebrospinal fluid leak, or recent cranial surgery or trauma.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin Dist, 807
About this study
Official title: Feasibility of a Respiratory Therapist-Supported Home Noninvasive Ventilation Program in Stable Severe COPD Without Hypercapnia
Chronic obstructive pulmonary disease (COPD) can cause persistent breathing problems, reduced exercise capacity, and repeated worsening of symptoms. Noninvasive ventilation (NIV) provides breathing support through a mask. Although NIV is commonly used in patients with respiratory failure, its role in patients with stable severe COPD without hypercapnia is less clear.
The purpose of this study was to evaluate the feasibility of a respiratory therapist-supported home NIV program and to explore its potential clinical effects in adults with stable severe COPD without hypercapnia. Participants used a bilevel positive airway pressure device at home for at least 6 hours per day for 3 months. Respiratory therapists provided education and helped set up and adjust the device in collaboration with physicians according to each participant's comfort and breathing pattern.
Read more
Participants were assessed before starting home NIV and after 1 and 3 months of treatment. Assessments included walking capacity, lung function, arterial blood gas measurements, breathing symptoms, and COPD-related health status. The study also evaluated participants' ability to tolerate and continue home NIV.
The findings were intended to determine whether a respiratory therapist-supported home NIV program is practical and potentially beneficial for patients with stable severe COPD without hypercapnia.
- Conditions
- COPD
- Being tested
- BreathePal Bilevel Positive Pressure System (GFM50-MD2201)
- Keywords
- COPD
- 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.
BreathePal Bilevel Positive Pressure System (GFM50-MD2201)Device
Participants used the BreathePal Bilevel Positive Pressure System (GFM50-MD2201) at home for at least 6 hours per day for 3 months. Initial inspiratory positive airway pressure (IPAP) was set at 10 cm H2O and expiratory positive airway pressure (EPAP) at 5 cm H2O. Settings could be adjusted by respiratory therapists according to physician instructions, participant comfort, ventilator synchrony, and clinical response.
| Study group | Role | What they receive |
|---|---|---|
| Home Noninvasive Ventilation | Experimental | Participants received respiratory therapist-supported home noninvasive ventilation using the BreathePal Bilevel Positive Pressure System for at least 6 hours per day for 3 months. Respiratory therapists provided device setup, education, and adjustment of ventilator settings in collaboration with physicians according to participant comfort, ventilator synchrony, and clinical condition. Receives: Device: BreathePal Bilevel Positive Pressure System (GFM50-MD2201) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COPD Assessment Test (CAT) Score From Baseline to 12 Weeks
The COPD Assessment Test (CAT) is an 8-item questionnaire assessing the impact of chronic obstructive pulmonary disease (COPD) on health status. The total score ranges from 0 to 40, with higher scores indicating worse health status and a greater impact of COPD.
Measured: Change in COPD Assessment Test (CAT) Score From Baseline to 12 Weeks
Change in Daytime Arterial Blood Gas From Baseline to 12 Weeks
Measured: Baseline and 12 weeks
Change in Modified Medical Research Council (mMRC) Dyspnea Scale From Baseline to 12 Weeks
The Modified Medical Research Council (mMRC) Dyspnea Scale is a 5-point scale ranging from 0 to 4 that assesses the severity of dyspnea during physical activity. Higher scores indicate more severe dyspnea and a worse outcome.
Measured: Change in Modified Medical Research Council (mMRC) Dyspnea Scale From Baseline to 12 Weeks
Secondary outcomes (4)
Change in 6MWD Dyspnea Scale From Baseline to 12 Weeks
The 6-Minute Walk Distance (6MWD) is the distance walked in meters during a standardized 6-minute walk test. Higher 6MWD values indicate better functional exercise capacity. The 6MWD is a continuous distance measure rather than a rating scale; therefore, no fixed minimum or maximum score applies.
Measured: Change in 6-Minute Walk Distance (6MWD) From Baseline to 12 Weeks
Change in Forced Expiratory Volume in 1 Second (FEV₁) From Baseline to 12 Weeks
Lung function will be assessed by spirometry. Forced expiratory volume in 1 second (FEV₁), measured in liters (L), will be recorded at baseline and 12 weeks. The change in FEV₁ from baseline to 12 weeks will be reported
Measured: Baseline and 12 Weeks
Change in Forced Vital Capacity From Baseline to 12 Weeks
Lung function will be assessed by spirometry. Forced Vital Capacity (FVC), measured in liters (L), will be recorded at baseline and 12 weeks. The change in FVC from baseline to 12 weeks will be reported.
Measured: Baseline and 12 Weeks
Change in FEV₁/FVC Ratio From Baseline to 12 Weeks
Lung function will be assessed by spirometry. The FEV₁/FVC ratio will be calculated from the forced expiratory volume in 1 second (FEV₁) and forced vital capacity (FVC). The FEV₁/FVC ratio will be reported as a percentage, and the change from baseline to 12 weeks will be summarized.
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start18 Jan 2024
- Primary completion17 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777497
- Sponsor's protocol ID
- KMUHIRB-F(I)-20230158
- Acronym
- COPD
- Status last verified
- Oct 2024
- First submitted
- 12 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Respiratory Therapist-Supported Home Noninvasive Ventilation Program in Stable Severe COPD Without Hypercapnia
- ClinicalTrials.gov ID
- NCT07777497
- Acronym / sponsor ID
- COPD / KMUHIRB-F(I)-20230158
- Conditions
- COPD
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 20 Aug 2026 (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.
Chronic obstructive pulmonary disease (COPD) can cause persistent breathing problems, reduced exercise capacity, and repeated worsening of symptoms. Noninvasive ventilation (NIV) provides breathing support through a mask. Although NIV is commonly used in patients with respiratory failure, its role in patients with stable severe COPD without hypercapnia is less clear.
The purpose of this study was to evaluate the feasibility of a respiratory therapist-supported home NIV program and to explore its potential clinical effects in adults with stable severe COPD without hypercapnia. Participants used a bilevel positive airway pressure device at home for at least 6 hours per day for 3 months. Respiratory therapists provided education and helped set up and adjust the device in collaboration with physicians according to each participant's comfort and breathing pattern.
Participants were assessed before starting home NIV and after 1 and 3 months of treatment. Assessments included walking capacity, lung function, arterial blood gas measurements, breathing symptoms, and COPD-related health status. The study also evaluated participants' ability to tolerate and continue home NIV.
The findings were intended to determine whether a respiratory therapist-supported home NIV program is practical and potentially beneficial for patients with stable severe COPD without hypercapnia.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Noninvasive Ventilation | Experimental | Device: BreathePal Bilevel Positive Pressure System (GFM50-MD2201)Participants received respiratory therapist-supported home noninvasive ventilation using the BreathePal Bilevel Positive Pressure System for at least 6 hours per day for 3 months. Respiratory therapists provided device setup, education, and adjustment of ventilator settings in collaboration with physicians according to participant comfort, ventilator synchrony, and clinical condition. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 20 years or older.
- Diagnosis of severe chronic obstructive pulmonary disease (COPD).
- Post-bronchodilator FEV1/FVC < 0.70.
- FEV1 < 50% of the predicted value with at least one moderate or severe COPD exacerbation in the previous year; or FEV1 50%-80% of the predicted value with at least two moderate exacerbations or at least one severe exacerbation in the previous year.
- Able to breathe spontaneously and not dependent on continuous bilevel positive airway pressure ventilation for life support.
Key exclusion criteria (8 listed)
- Pregnancy or suspected pregnancy.
- Hemodynamic instability.
- Recent facial surgery.
- Excessive or excessively thick respiratory secretions.
- Sleep apnea.
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 |
|---|---|---|
| BreathePal Bilevel Positive Pressure System (GFM50-MD2201)Participants used the BreathePal Bilevel Positive Pressure System (GFM50-MD2201) at home for at least 6 hours per day for 3 months. Initial inspiratory positive airway pressure (IPAP) was set at 10 cm H2O and expiratory positive airway pressure (EPAP) at 5 cm H2O. Settings could be adjusted by respiratory therapists according to physician instructions, participant comfort, ventilator synchrony, and clinical response. | Device | Home Noninvasive Ventilation |
Primary outcome
Change in COPD Assessment Test (CAT) Score From Baseline to 12 Weeks
Time frame: Change in COPD Assessment Test (CAT) Score From Baseline to 12 Weeks
The COPD Assessment Test (CAT) is an 8-item questionnaire assessing the impact of chronic obstructive pulmonary disease (COPD) on health status. The total score ranges from 0 to 40, with higher scores indicating worse health status and a greater impact of COPD.
Change in Daytime Arterial Blood Gas From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Change in Modified Medical Research Council (mMRC) Dyspnea Scale From Baseline to 12 Weeks
Time frame: Change in Modified Medical Research Council (mMRC) Dyspnea Scale From Baseline to 12 Weeks
The Modified Medical Research Council (mMRC) Dyspnea Scale is a 5-point scale ranging from 0 to 4 that assesses the severity of dyspnea during physical activity. Higher scores indicate more severe dyspnea and a worse outcome.
4 secondary outcomes
Change in 6MWD Dyspnea Scale From Baseline to 12 Weeks
Time frame: Change in 6-Minute Walk Distance (6MWD) From Baseline to 12 Weeks
Change in Forced Expiratory Volume in 1 Second (FEV₁) From Baseline to 12 Weeks
Time frame: Baseline and 12 Weeks
Change in Forced Vital Capacity From Baseline to 12 Weeks
Time frame: Baseline and 12 Weeks
Change in FEV₁/FVC Ratio From Baseline to 12 Weeks
Time frame: Baseline and 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BreathePal Bilevel Positive Pressure System (GFM50-MD2201) in people with COPD, run by Kaohsiung Medical University Chung-Ho 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 20 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in COPD Assessment Test (CAT) Score From Baseline to 12 Weeks (time frame: Change in COPD Assessment Test (CAT) Score From Baseline to 12 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.