Pulmonary Disease, Chronic ObstructiveNCT01684384
Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.
A study testing Functional Respiratory Imaging in people with Pulmonary Disease, Chronic Obstructive, run by FLUIDDA nv at 4 sites in 3 countries.
Trial summary
In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Functional Respiratory Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Sep 2012to Sep 2014
- Phase
- Interventional
- 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
- Male or female, ≥ 40 years old
- COPD as defined by the global Initiative on obstructive lung disease4
- Post-bronchodilator FEV1/FVC < 70% AND post-bronchodilator FEV1 <80%pred as documented in the last 5 years.
- Smoking history of at least 10 pack-years
- At entry in the study experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations, and that necessitates the administration or doubling of systemic corticosteroid treatment.
- Patients must be able to understand and complete protocol requirements, instructions, questionnaires and protocol-stated restrictions.
- Written and signed informed consent
Who cannot join
- Pregnant or lactating females
- Patient diagnosed with asthma
- Patient with pneumonia as defined radiologically at the start of the exacerbation
- Patient with a history of or presence of lung cancer
- Patient with an indication for non-invasive ventilation
- Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- Patient who received any investigational new drug within the last 4 weeks prior to visit 1.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Netherlands2 sites
University Medical Center Groningen
Groningen, 9700RB
Maastricht University Medical Center
Maastricht, 6229HX
About this study
Official title: Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.
In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values will be correlated with changes in patient reported outcomes (PROs) and lung function tests recorded at the same time.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Functional Respiratory Imaging
- Keywords
- Pulmonary Disease, Chronic Obstructive, COPD, Exacerbation, Functional Respiratory Imaging, High Resolution Computed Tomography, HRCT scan, Patient Reported Outcome, PRO, Computational Fluid Dynamic, CFD, Lung function parameters
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Respiratory ImagingRadiation
Also called HRCT scan
HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Experimental | CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention. Receives: Radiation: Functional Respiratory Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional respiratory imaging parameters
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
Measured: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Changes in lung function parameters
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
Measured: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Secondary outcomes (1)
Changes in patient reported outcome (PRO) measures
The secondary objective is to check if the changes in CFD data actually correlate better with changes in PRO than changes in lung function parameters.
Measured: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
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, AntwerpHuib AM Kerstjens, MD, Principal investigator, University Medical Center GroningenEmiel FM Wouters, MD, Principal investigator, Maastricht University Medical CenterMassimo Pistolesi, MD, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684384
- Sponsor's protocol ID
- FLUI-2011-79
- Status last verified
- Nov 2014
- First submitted
- 6 Sep 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.
- ClinicalTrials.gov ID
- NCT01684384
- Acronym / sponsor ID
- FLUI-2011-79
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, COPD, Exacerbation, Functional Respiratory Imaging, High Resolution Computed Tomography, HRCT scan, Patient Reported Outcome, PRO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Sep 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 study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values will be correlated with changes in patient reported outcomes (PROs) and lung function tests recorded at the same time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | Experimental | Radiation: Functional Respiratory ImagingCT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, ≥ 40 years old
- COPD as defined by the global Initiative on obstructive lung disease4
- Post-bronchodilator FEV1/FVC < 70% AND post-bronchodilator FEV1 <80%pred as documented in the last 5 years.
- Smoking history of at least 10 pack-years
- At entry in the study experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations, and that necessitates the administration or doubling of systemic corticosteroid treatment.
Key exclusion criteria (7 listed)
- Pregnant or lactating females
- Patient diagnosed with asthma
- Patient with pneumonia as defined radiologically at the start of the exacerbation
- Patient with a history of or presence of lung cancer
- Patient with an indication for non-invasive ventilation
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 ImagingAlso: HRCT scanHRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering. | Radiation | No treatment |
Primary outcome
Changes in functional respiratory imaging parameters
Time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
Changes in lung function parameters
Time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
1 secondary outcome
Changes in patient reported outcome (PRO) measures
Time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 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
Huib AM Kerstjens, MD principal investigator
University Medical Center Groningen
Emiel FM Wouters, MD principal investigator
Maastricht University Medical Center
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Respiratory Imaging in people with Pulmonary Disease, Chronic Obstructive, run by FLUIDDA nv at 4 sites in 3 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 7 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: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Belgium, Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 functional respiratory imaging parameters (time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)). The study lists 2 primary outcomes in all. 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 2 Dec 2014.