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

NCT01592656 | Terminated Phase 2

• 1 other identifier: FLUI-2010-68
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Health related quality of life

  At baseline, after 1 month and after 6 months

• Lung function tests

  At baseline, after 1 month and after 6 months

• Hospital admissions

  After 1 month and after 6 months

• Exercise tolerance

  At baseline, after 1 month and after 6 months

• Local airway volume and resistance

  At baseline, after 1 month and after 6 months

Study Arms (2)

Non-invasive ventilation (NIV)

ACTIVE COMPARATOR

30 patients will receive NIV during 6 months = group 1

Radiation: Functional Respiratory Imaging; Other: Lung compliance measurement; Device: Non-invasive ventilation (Respironics)

Control group

PLACEBO COMPARATOR

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

Radiation: Functional Respiratory Imaging; Other: Lung compliance measurement

Interventions

Functional Respiratory Imaging RADIATION

CT-scan of thorax. At baseline, after 1 month and after 6 months.

Control group; Non-invasive ventilation (NIV)

Lung compliance measurement OTHER

At baseline

Control group; Non-invasive ventilation (NIV)

Non-invasive ventilation (Respironics) DEVICE

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.

Also known as: Trilogy device (Respironics)

Non-invasive ventilation (NIV)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• FLUIDDA nv: lead

Study Sites (2)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

University Medical Center Groningen

Groningen, 9700, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Wilfried De Backer, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

• Peter Wijkstra, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: February 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 16, 2014

Record last verified: 2012-10

Locations

BE (1); NL (1)