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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01592656
Other study ID # FLUI-2010-68
Secondary ID
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


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
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