COPD
Feasibility of a Respiratory Therapist-Supported Home Noninvasive Ventilation Program in Stable Severe COPD Without Hypercapnia
Sponsor study identifier
interventional
14
1 country
1
Study Start
January 18, 2024
Actual (reported)Primary Completion
October 17, 2024
Actual (reported)Study Completion
October 31, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2024
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 18, 2024
Actual (reported)October 17, 2024
Actual (reported)October 31, 2024
Actual (reported)August 12, 2026
Actual (reported)August 20, 2026
Actual (reported)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 COPD Assessment Test (CAT) Score From Baseline to 12 Weeks
Change in Daytime Arterial Blood Gas From Baseline to 12 Weeks
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.
Change in Modified Medical Research Council (mMRC) Dyspnea Scale From Baseline to 12 Weeks
Change in 6MWD Dyspnea Scale From Baseline to 12 Weeks
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
Baseline and 12 Weeks
Change in Forced Vital Capacity From Baseline to 12 Weeks
Baseline and 12 Weeks
Change in FEV₁/FVC Ratio From Baseline to 12 Weeks
Baseline and 12 Weeks
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin Dist, 807, Taiwan
14 participants (actual enrollment reported by the registry).
First Submitted
August 12, 2026
First Posted
August 20, 2026
Study Start
January 18, 2024
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 17, 2024
Actual (reported)Study Completion
October 31, 2024
Actual (reported)Last Updated
August 20, 2026
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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