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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01592656
• Other study ID #: FLUI-2010-68
• Status: Terminated
• Phase: Phase 2
• First received: May 3, 2012
• Last updated: January 15, 2014
• Start date: February 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2012
• Source: FLUIDDA nv
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
FLUIDDA nv

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	Lung function tests	Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)	At baseline, after 1 month and after 6 months	No
Secondary	Hospital admissions	Length and frequency of admission, severity of exacerbations, ICU admissions	After 1 month and after 6 months	No
Secondary	Exercise tolerance	6 minutes walking test and oximetry measurement	At baseline, after 1 month and after 6 months	No
Secondary	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	No
Secondary	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	No