Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients

Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.

In this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q) matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan will be used for FRI.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Radiation: Functional Respiratory Imaging; Other: Lung compliance measurement; Device: Non-invasive ventilation (Respironics)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital
• Netherlands
  • Groningen, Netherlands, 9700
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: ≥ 40 years old
• Men and women
• Written informed consent obtained
• COPD patients GOLD II, III and IV
• Persisting hypercapnia (pCO2 > 45 mmHg ) notwithstanding adequate treatment modalities (including oxygen) as proposed by the GOLD guidelines
• Stopped smoking
• Total lung capacity (TLC) > 85%

Exclusion Criteria:

• Treatment with home NIV or Continuous Positive Airway Pressure (CPAP)
• Asthma
• Restrictive lung disease
• Symptomatic or uncontrolled heart failure
• Current malignancy
• Suspected bad compliance for NIV treatment
• Pregnant women
• Not be able to speak the language of the participating center
• Received an investigational product within 4 weeks prior to inclusion in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-invasive ventilation (NIV); 30 patients will receive NIV during 6 months = group 1	Radiation: Functional Respiratory Imaging; CT-scan of thorax. At baseline, after 1 month and after 6 months.; Other: Lung compliance measurement; At baseline; Device: Non-invasive ventilation (Respironics); Long-term non-invasive ventilation, starting at baseline until 6 months. At baseline the patients should have persisting hypercapnia (pCO2 > 45 mmHg) under optimal conservative treatment other than NIV. The patients can be hospitalised or being treated at home at inclusion.; Other Names: Trilogy device (Respironics)
Placebo Comparator: Control group; 10 patients will act as control group, they will not be treated with NIV = group 2	Radiation: Functional Respiratory Imaging; CT-scan of thorax. At baseline, after 1 month and after 6 months.; Other: Lung compliance measurement; At baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the distribution of the mass flow per lobe and the relative proportion of bloodvessels, as obtained from functional respiratory imaging (FRI) and arterial blood gas (ABG).	The primary objective of this study is the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for V/Q matching) with FRI and ABG values in hypercapnic COPD patients treated with long-term NIV.	At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire	At baseline, after 1 month and after 6 months
Lung function tests	Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)	At baseline, after 1 month and after 6 months
Hospital admissions	Length and frequency of admission, severity of exacerbations, ICU admissions	After 1 month and after 6 months
Exercise tolerance	6 minutes walking test and oximetry measurement	At baseline, after 1 month and after 6 months
Local airway volume and resistance	CT-scan of thorax. CT scan is performed with a low radiation protocol. These images are made to perform computational fluid dynamics on in order to obtain more information on regional lung function characteristics.	At baseline, after 1 month and after 6 months
Prediction of breathing pattern	The tertiary objective of the study is to predict the breathing pattern (including tidal volume) during NIV when using the data of patient specific lobar compliance and regional resistance at baseline.	At baseline

Collaborators and Investigators

• Sponsor: FLUIDDA nv
• Investigators: Principal Investigator: Peter Wijkstra, MD, PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: May 4, 2012
• First Posted (Estimate): May 7, 2012

Study Record Updates

• Last Update Posted (Estimate): January 16, 2014
• Last Update Submitted That Met QC Criteria: January 15, 2014
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Non-Invasive Ventilation; Health Related Quality of Life; Functional Respiratory Imaging; Hypercapnic; Lung compliance; GOLD stages II, III and IV; Computed Tomography scan; Arterial Blood Gas
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypercapnia
• Other Study ID Numbers: FLUI-2010-68