NCT07777497Completed
Respiratory Therapist-Supported Home Noninvasive Ventilation in Stable Severe COPD Without Hypercapnia
Feasibility of a Respiratory Therapist-Supported Home Noninvasive Ventilation Program in Stable Severe COPD Without Hypercapnia
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 12 Aug 2026
- Start date
- 18 Jan 2024
- Primary completion date
- 17 Oct 2024
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Diseases
- COPD
- NCT number
- NCT07777497
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 18 Jan 2024 to the primary completion date, 17 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent facial surgery.
- Contraindications to noninvasive positive-pressure ventilation, including acute sinusitis, otitis media, pneumothorax, pathological hypotension, dehydration, cerebrospinal fluid leak, or recent cranial surgery or trauma.
Other illness
- Significant comorbid disease, such as left ventricular failure.
Other
- Pregnancy or suspected pregnancy.
- Hemodynamic instability.
- Excessive or excessively thick respiratory secretions.
- Sleep apnea.
- Other causes of chronic airway obstruction, such as bronchiectasis.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.