Chronic Obstructive Pulmonary DiseasePhase 2NCT01592656
Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 2 study testing Functional Respiratory Imaging, Lung compliance measurement and Non-invasive ventilation (Respironics) in people with Chronic Obstructive Pulmonary Disease, run by FLUIDDA nv at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Functional Respiratory Imaging, Lung compliance measurement and Non-invasive ventilation (Respironics)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2011to Oct 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.
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
- Being tested
- Functional Respiratory Imaging, Lung compliance measurement, Non-invasive ventilation (Respironics)
- 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Respiratory ImagingRadiation
CT-scan of thorax. At baseline, after 1 month and after 6 months.
Lung compliance measurementOther
At baseline
Non-invasive ventilation (Respironics)Device
Also called Trilogy device (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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive ventilation (NIV) | Active comparator | 30 patients will receive NIV during 6 months = group 1 Receives: 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 Receives: Radiation: Functional Respiratory Imaging; Other: Lung compliance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV)
Secondary outcomes (6)
Health related quality of life
Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire
Measured: At baseline, after 1 month and after 6 months
Lung function tests
Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)
Measured: At baseline, after 1 month and after 6 months
Hospital admissions
Length and frequency of admission, severity of exacerbations, ICU admissions
Measured: After 1 month and after 6 months
Exercise tolerance
6 minutes walking test and oximetry measurement
Measured: At baseline, after 1 month and after 6 months
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.
Measured: At baseline, after 1 month and after 6 months
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startFeb 2011
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Lack of budget
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FLUIDDA nv
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried De Backer, MD, PhD, Principal investigator, University Hospital, AntwerpPeter Wijkstra, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592656
- Sponsor's protocol ID
- FLUI-2010-68
- Status last verified
- Oct 2012
- First submitted
- 3 May 2012
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.
- ClinicalTrials.gov ID
- NCT01592656
- Acronym / sponsor ID
- FLUI-2010-68
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of budget
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive ventilation (NIV) | Active comparator | Radiation: Functional Respiratory Imaging, Other: Lung compliance measurement, Device: Non-invasive ventilation (Respironics)30 patients will receive NIV during 6 months = group 1 |
| Control group | Placebo comparator | Radiation: Functional Respiratory Imaging, Other: Lung compliance measurement10 patients will act as control group, they will not be treated with NIV = group 2 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Treatment with home NIV or Continuous Positive Airway Pressure (CPAP)
- Asthma
- Restrictive lung disease
- Symptomatic or uncontrolled heart failure
- Current malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Respiratory ImagingCT-scan of thorax. At baseline, after 1 month and after 6 months. | Radiation | Control group, Non-invasive ventilation (NIV) |
| Lung compliance measurementAt baseline | Other | Control group, Non-invasive ventilation (NIV) |
| Non-invasive ventilation (Respironics)Also: Trilogy device (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. | Device | Non-invasive ventilation (NIV) |
Primary outcome
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)
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.
6 secondary outcomes
Health related quality of life
Time frame: At baseline, after 1 month and after 6 months
Lung function tests
Time frame: At baseline, after 1 month and after 6 months
Hospital admissions
Time frame: After 1 month and after 6 months
Exercise tolerance
Time frame: At baseline, after 1 month and after 6 months
Local airway volume and resistance
Time frame: At baseline, after 1 month and after 6 months
Prediction of breathing pattern
Time frame: At baseline
Results and safety
The study was stopped early (reason given: Lack of budget). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried De Backer, MD, PhD principal investigator
University Hospital, Antwerp
Peter Wijkstra, MD, PhD principal investigator
University Medical Center Groningen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Functional Respiratory Imaging, Lung compliance measurement and Non-invasive ventilation (Respironics) in people with Chronic Obstructive Pulmonary Disease, run by FLUIDDA nv at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of budget). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.