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

Phase 2

Terminated

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

• Registration Number: NCT01592656
• Lead Sponsor: FLUIDDA nv

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-07
• Status Verified: 2012-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2014-01-15
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Functional Respiratory Imaging	10 patients will act as control group, they will not be treated with NIV = group 2
Non-invasive ventilation (NIV)	Functional Respiratory Imaging	30 patients will receive NIV during 6 months = group 1
Non-invasive ventilation (NIV)	Lung compliance measurement	30 patients will receive NIV during 6 months = group 1
Non-invasive ventilation (NIV)	Non-invasive ventilation (Respironics)	30 patients will receive NIV during 6 months = group 1
Control group	Lung compliance measurement	10 patients will act as control group, they will not be treated with NIV = group 2

Primary Outcome Measures

Name	Time	Method
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).	At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV)	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.

Secondary Outcome Measures

Name	Time	Method
Local airway volume and resistance	At baseline, after 1 month and after 6 months	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.
Prediction of breathing pattern	At baseline	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.
Health related quality of life	At baseline, after 1 month and after 6 months	Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire
Lung function tests	At baseline, after 1 month and after 6 months	Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)
Hospital admissions	After 1 month and after 6 months	Length and frequency of admission, severity of exacerbations, ICU admissions
Exercise tolerance	At baseline, after 1 month and after 6 months	6 minutes walking test and oximetry measurement

Trial Locations

Locations (2)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands