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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Functional Respiratory Imaging
Lung compliance measurement
Non-invasive ventilation (Respironics)
Sponsored by
FLUIDDA nv
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, GOLD stages II, III and IV, Computed Tomography scan, Functional Respiratory Imaging, Non-Invasive Ventilation, Arterial Blood Gas, Hypercapnic, Health Related Quality of Life, Lung compliance

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Antwerp University Hospital
  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Non-invasive ventilation (NIV)

Control group

Arm Description

30 patients will receive NIV during 6 months = group 1

10 patients will act as control group, they will not be treated with NIV = group 2

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Health related quality of life
Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire
Lung function tests
Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)
Hospital admissions
Length and frequency of admission, severity of exacerbations, ICU admissions
Exercise tolerance
6 minutes walking test and oximetry measurement
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.
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.

Full Information

First Posted
May 3, 2012
Last Updated
January 15, 2014
Sponsor
FLUIDDA nv
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1. Study Identification

Unique Protocol Identification Number
NCT01592656
Brief Title
Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of budget
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FLUIDDA nv

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, GOLD stages II, III and IV, Computed Tomography scan, Functional Respiratory Imaging, Non-Invasive Ventilation, Arterial Blood Gas, Hypercapnic, Health Related Quality of Life, Lung compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-invasive ventilation (NIV)
Arm Type
Active Comparator
Arm Description
30 patients will receive NIV during 6 months = group 1
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
10 patients will act as control group, they will not be treated with NIV = group 2
Intervention Type
Radiation
Intervention Name(s)
Functional Respiratory Imaging
Intervention Description
CT-scan of thorax. At baseline, after 1 month and after 6 months.
Intervention Type
Other
Intervention Name(s)
Lung compliance measurement
Intervention Description
At baseline
Intervention Type
Device
Intervention Name(s)
Non-invasive ventilation (Respironics)
Other Intervention Name(s)
Trilogy device (Respironics)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV)
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire
Time Frame
At baseline, after 1 month and after 6 months
Title
Lung function tests
Description
Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)
Time Frame
At baseline, after 1 month and after 6 months
Title
Hospital admissions
Description
Length and frequency of admission, severity of exacerbations, ICU admissions
Time Frame
After 1 month and after 6 months
Title
Exercise tolerance
Description
6 minutes walking test and oximetry measurement
Time Frame
At baseline, after 1 month and after 6 months
Title
Local airway volume and resistance
Description
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.
Time Frame
At baseline, after 1 month and after 6 months
Title
Prediction of breathing pattern
Description
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.
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Backer, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Wijkstra, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700
Country
Netherlands

12. IPD Sharing Statement

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

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