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

This study has been terminated.
(Lack of budget)
Sponsor:
Information provided by (Responsible Party):
FluidDA nv
ClinicalTrials.gov Identifier:
NCT01592656
First received: May 3, 2012
Last updated: January 15, 2014
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Radiation: Functional Respiratory Imaging
Other: Lung compliance measurement
Device: Non-invasive ventilation (Respironics)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.

Resource links provided by NLM:


Further study details as provided by FluidDA nv:

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). [ Time Frame: At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV) ] [ Designated as safety issue: No ]
    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 [ Time Frame: At baseline, after 1 month and after 6 months ] [ Designated as safety issue: No ]
    Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire

  • Lung function tests [ Time Frame: At baseline, after 1 month and after 6 months ] [ Designated as safety issue: No ]
    Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)

  • Hospital admissions [ Time Frame: After 1 month and after 6 months ] [ Designated as safety issue: No ]
    Length and frequency of admission, severity of exacerbations, ICU admissions

  • Exercise tolerance [ Time Frame: At baseline, after 1 month and after 6 months ] [ Designated as safety issue: No ]
    6 minutes walking test and oximetry measurement

  • Local airway volume and resistance [ Time Frame: At baseline, after 1 month and after 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: February 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592656

Locations
Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700
Sponsors and Collaborators
FluidDA nv
Investigators
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
Principal Investigator: Peter Wijkstra, MD, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: FluidDA nv
ClinicalTrials.gov Identifier: NCT01592656     History of Changes
Other Study ID Numbers: FLUI-2010-68
Study First Received: May 3, 2012
Last Updated: January 15, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by FluidDA nv:
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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypercapnia
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014