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Completed

NCT Number: NCT07777497

Respiratory Therapist-Supported Home Noninvasive Ventilation 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.

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 807, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Change in Daytime Arterial Blood Gas From Baseline to 12 Weeks

    Time frame: Baseline and 12 weeks

  3. 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.

Secondary outcomes

  1. Change in 6MWD Dyspnea Scale From Baseline to 12 Weeks

    Time frame: Change in 6-Minute Walk Distance (6MWD) 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.

  2. Change in Forced Expiratory Volume in 1 Second (FEV₁) From Baseline to 12 Weeks

    Time frame: Baseline and 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

  3. Change in Forced Vital Capacity From Baseline to 12 Weeks

    Time frame: Baseline and 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.

  4. Change in FEV₁/FVC Ratio From Baseline to 12 Weeks

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

Feasibility of a Respiratory Therapist-Supported Home Noninvasive Ventilation Program in Stable Severe COPD Without Hypercapnia

Acronym: COPD

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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