NCT03053973Completed
The Effects of Nocturnal Non-invasive Ventilation in Stable COPD
Nocturnal Non-Invasive Ventilation in COPD Patients With Stable Hypercapnic Respiratory Failure: Why and in Which Patient Might This be Effective?
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
Rationale: Application of long-term non-invasive ventilation (NIV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve outcomes. However, the mechanism behind these improvements are unknown. We hypothesize that NIV stabilizes FEV1 via beneficial effects on inflammation and repair pathways in patients with COPD. In the present study we aim to investigate, in COPD patients with CHRF, 1. change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPD patients as compared to standard care 2. the relationship between FEV1 change and modification of systemic and airway inflammation and remodelling, lung hyperinflation, and airway morphology. 3. predictors of a favourable response to chronic NIV in COPD patients with CHRF. Study design: multicentre randomised controlled study investigating the effects of NIV on airway morphology, airway inflammation and remodelling in hypercapnic COPD patients including a control group that will postpone the initiation of NIV for 3 months. In addition we will investigate how patient demographics, patient and disease characteristics and systemic and airway inflammation predict the response to chronic NIV in severe stable COPD. To do this, all patients will be followed for 6 months after NIV initiation. Main study parameters/endpoints: The main endpoint is the change FEV1 after 3 months. Furthermore, as we recognise that FEV1 might not be the most important patient-related outcome, we will assess which parameters affect health-related quality of life after 3 and 6 months.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 116 (actual)
- First submitted
- 8 Feb 2017
- Start date
- 13 Nov 2017
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- University Medical Center Groningen
- Diseases
- COPD
- NCT number
- NCT03053973
What you commit to
- Study type: Interventional
- Participants enrolled: 116
- From 13 Nov 2017 to the primary completion date, 1 Aug 2025
- 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
- Oral corticosteroids or roflumilast
Other illness
- A history of lung volume reduction surgery
Lab values
- Instable cardiac comorbidities (left ventricular ejection fraction (LVEF) \<40%, instable coronary artery disease, instable heart failure)
Other
- For the randomised Inflammation part a potential subject who meets any of the following criteria will be excluded from participation in this study:
- Body mass index (BMI) \> 35 kg/m2
- Obstructive sleep apnoea (OSA) (apnoea/hypopnea index (AHI) \>15/hr): to exclude OSA a polygraphy will be done at baseline
- PaCO2 ≥ 8.0 kPa or PaO2 \< 6.5 kPa at rest without oxygen
Who the study is looking for
- Indication to initiate chronic NIV in COPD patients (GOLD stage III or IV: FEV1/ forced expiratory volume (FVC)\< 70% and FEV1\< 50% predicted; PaCO2 \> 6.0 kilopascal (kPa) in stable condition, which means no COPD exacerbation for 4 weeks and a pH \> 7.35)
- Age \> 18 years
- Written informed consent is obtained
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.