The Effects of Nocturnal Non-invasive Ventilation in Stable COPD

NCT03053973 | Unknown DMC

• 1 other identifier: 201700097
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPD patients as compared to standard care
2. 2.the relationship between FEV1 change and modification of systemic and airway inflammation and remodelling, lung hyperinflation, and airway morphology.
3. 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.

Conditions

Noninvasive Ventilation

Keywords

COPD; airway inflammation; airway remodeling; health-related auality of life; forced expiratory volume 1 second

Outcome Measures

Primary Outcomes (2)

• FEV1

  Change in Forced expiratory volume in one second

  baseline, 3 months

• Health-Related Quality of Life

  Change in HRQoL assessed by the severe respiratory insufficiency questionnaire summary score (SRI)

  baseline, 3 months, 6 months

Secondary Outcomes (22)

• Safety: the number of adverse events will be recorded.

  baseline, 3 months, and 6 months

• Health-related quality of life assessed with the SF-36

  baseline, 3 months, 6 months

• Anxiety and depression

  baseline, 3 months, 6 months

• Activities and Restrictions,

  baseline, 3 months, 6 months

• Caregiver Burden

  baseline, 3 months, 6 months

Study Arms (2)

NIV directly started arm

EXPERIMENTAL

Patients randomised to this arm will start noninvasive ventilation after baseline measurements are performed.

Device: nocturnal noninvasive ventilation; Other: Standard Care

NIV postponed arm

OTHER

Patients randomised to this arm will, after baseline measurements have been done, first be followed for 3 months while on standard care, and thus serve as the control arm. After this 3 months period, measurements are repeated and patients will also be initiated on noninvasive ventilation.

Device: nocturnal noninvasive ventilation; Other: Standard Care

Interventions

nocturnal noninvasive ventilation DEVICE

Patients will be initiated on bilevel positive pressure non-invasive ventilation via a mask according to regular clinical practice.

NIV directly started arm; NIV postponed arm

Standard Care OTHER

Standard COPD care is given to all patients (pharmacological management, oxygen, rehabilitation if neccesary, etc.)

NIV directly started arm; NIV postponed arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• For the randomised Inflammation part a potential subject who meets any of the following criteria will be excluded from participation in this study:
• Oral corticosteroids or roflumilast
• A history of lung volume reduction surgery
• 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
• Instable cardiac comorbidities (left ventricular ejection fraction (LVEF) \<40%, instable coronary artery disease, instable heart failure)

Sponsors & Collaborators

• Peter Wijkstra: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

Related Publications (1)

• Boersma R, Bakker JT, de Vries M, Raveling T, Slebos DJ, Wijkstra PJ, Hartman JE, Duiverman ML. Defining a phenotype of severe COPD patients who develop chronic hypercapnia. Respir Med. 2024 Nov-Dec;234:107850. doi: 10.1016/j.rmed.2024.107850. Epub 2024 Oct 31.

  PMID: 39488255 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Airway Remodeling

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Peter J Wijkstra, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. P.J.Wijkstra

Model Details: Parallel groups non-blinded randomised controlled trial

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 15, 2017
• Study Start: November 13, 2017
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

NL (1)