Chronic Obstructive Pulmonary DiseaseACQUAVIPNCT03337854
Analysis With Clusters of QUAntitative Tomodensitometric Vascular, bronchIal and Parenchymal Pulmonary Parameters for COPD Patients
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is caused by tobacco consumption. The goal is to characterize on clinical and radiological data, using computed tomography, this illness in order to improve diagnostic and be able to evaluate the prognostic of each patient. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2017to 1 Dec 2018
- Phase
- Observational
- 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
Study population: Population with an age ≥ 40 years and inhalated toxic exposure like Tobacco exposure (present or past, over 10 pack years) and/or professional exposure to a toxic, in presence of obstructive syndrome with a FEV1/FVC ≤ 0.7 after inhalation of a bronchodilatator and measured at stable state (without exacerbation).
Who may be able to join
- Age ≥ 40 years
- Inhalated toxic exposure:
- Tobacco exposure (present or past, over 10 pack years)
- And/or professional exposure to a toxic
- Obstructive syndrome with a FEV1/FVC ≤ 0.7 after inhalation of a bronchodilatator and measured at stable state (without exacerbation)
- Computed tomography performed without injection contrast during common care
Who cannot join
- Patients with an exacerbation within 6 weeks before computed tomography
- Artefacts movements on computed tomography incompatible with quantitative analyse
- Broncho-pulmonary cancer (old or present)
- History of pulmonary surgery
- No follow-up for 1 year after scan
- Opposition of the patient to the use of his data (clinical, functional and imaging).
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33000
François LAURENT, MD, PhD, +335 57 65 63 68, francois.laurent@chu-bordeaux.fr
Rkia ACHKIR, +335 57 62 32 52, rkia.achkir@chu-bordeaux.fr
About this study
Chronic obstructive pulmonary disease (COPD) is caused by tobacco consumption. The goal is to characterize on clinical and radiological data, using computed tomography, this illness in order to improve diagnostic and be able to evaluate the prognostic of each patient.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is characterized by emphysematous destruction of pulmonary parenchyma, airway obstruction that participate in chronic temporary obstruction of airways. COPD has multiple clinical presentations that define phenotypes but doesn't take into account those anatomo-pathologic modifications. Moreover, the prognostic interest of those structural alteration is unknown. Until now, only PFT allowed to define the severity of the disease, whereas multiple others tools may be useful, such as, symptoms scores, exacerbation frequencies, denutrition. Those structural alterations are available using computed tomography (CT), that may also have an interest in prognostic or in treatment follow- up.
CT is widely used in clinical practice for COPD patients at basal state and in exacerbations. Quantitative CT is able to combine acquisition of objective and reproductible informations on parenchymal destruction (emphysema), bronchial wall remodeling, and pulmonary vessels alteration. The investigators' team developed software tools to determine quantitative structural modifications of airways, emphysema and small pulmonary vessels1,2.
The team has been able to build a score "Paw score" combining PaO2 with CT parameters of bronchial wall thickness and small pulmonary vessels percentage2. This score allowed to predict the presence of severe pulmonary hypertension in patients with COPD. Pulmonary hypertension is a complication of COPD that increase morbi-mortality.
The hypothesis is that morphological quantitative analysis combined with structural alterations of airways has a prognostic interest.
The main goal is to determine morphological phenotypes of COPD using a cluster analysis combining emphysema, bronchial wall thickness and pulmonary vessels.
The other main goal is to predict evolution of COPD patients based on clinical outcomes (exacerbations frequency, mortality, mMRC, SGQLQ) and lung function testing (decline in FEV-1 TLCO, PaO2).
The team also wants to analyze clinical data of survival, exacerbation and symptoms in following years of the CT of each cluster in historic-prospective way.
The secondary goals are to describe clinical, functional and biological clusters. Analyse of correlations will be studied. Moreover, we will investigate the interest of the "Paw score" as a prognostic marker and as a correlated parameter.
This is a retrospective study. We want to take information from the year before CT, to the year after CT. At the date of the consultation concomitant with CT we want to know all the clinical, functional and biological data of each patient.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- prognostic, phenotype, Computed tomography, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypes of Chronic obstructive pulmonary disease (COPD)
Measure of emphysema
Measured: Day 1
Phenotypes of Chronic obstructive pulmonary disease (COPD)
Measure of proximal bronchial wall thickness
Measured: Day 1
Phenotypes of Chronic obstructive pulmonary disease (COPD)
Measure of dimensions of the pulmonary arteries
Measured: Day 1
Phenotypes of Chronic obstructive pulmonary disease (COPD)
Measure of ratio of main pulmonary artery over aoarta diameter
Measured: Day 1
Secondary outcomes (2)
Clinical data of survival
Date of death
Measured: Day 1
Exacerbations
Number of exacerbations
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start20 Dec 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
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.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Transitionnal Research International Laboratory
- Responsible party
- Sponsor
- Investigators
- François LAURENT, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337854
- Sponsor's protocol ID
- 2017/44
- Acronym
- ACQUAVIP
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis With Clusters of QUAntitative Tomodensitometric Vascular, bronchIal and Parenchymal Pulmonary Parameters for COPD Patients
- ClinicalTrials.gov ID
- NCT03337854
- Acronym / sponsor ID
- ACQUAVIP / 2017/44
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- prognostic, phenotype, Computed tomography, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Transitionnal Research International Laboratory
- Study start
- 20 Dec 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 9 Nov 2017 (actual)
- 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.
Chronic obstructive pulmonary disease (COPD) is caused by tobacco consumption. The goal is to characterize on clinical and radiological data, using computed tomography, this illness in order to improve diagnostic and be able to evaluate the prognostic of each patient.
Detailed description
Chronic obstructive pulmonary disease (COPD) is characterized by emphysematous destruction of pulmonary parenchyma, airway obstruction that participate in chronic temporary obstruction of airways. COPD has multiple clinical presentations that define phenotypes but doesn't take into account those anatomo-pathologic modifications. Moreover, the prognostic interest of those structural alteration is unknown. Until now, only PFT allowed to define the severity of the disease, whereas multiple others tools may be useful, such as, symptoms scores, exacerbation frequencies, denutrition. Those structural alterations are available using computed tomography (CT), that may also have an interest in prognostic or in treatment follow- up.
CT is widely used in clinical practice for COPD patients at basal state and in exacerbations. Quantitative CT is able to combine acquisition of objective and reproductible informations on parenchymal destruction (emphysema), bronchial wall remodeling, and pulmonary vessels alteration. The investigators' team developed software tools to determine quantitative structural modifications of airways, emphysema and small pulmonary vessels1,2.
The team has been able to build a score "Paw score" combining PaO2 with CT parameters of bronchial wall thickness and small pulmonary vessels percentage2. This score allowed to predict the presence of severe pulmonary hypertension in patients with COPD. Pulmonary hypertension is a complication of COPD that increase morbi-mortality.
The hypothesis is that morphological quantitative analysis combined with structural alterations of airways has a prognostic interest.
The main goal is to determine morphological phenotypes of COPD using a cluster analysis combining emphysema, bronchial wall thickness and pulmonary vessels.
The other main goal is to predict evolution of COPD patients based on clinical outcomes (exacerbations frequency, mortality, mMRC, SGQLQ) and lung function testing (decline in FEV-1 TLCO, PaO2).
The team also wants to analyze clinical data of survival, exacerbation and symptoms in following years of the CT of each cluster in historic-prospective way.
The secondary goals are to describe clinical, functional and biological clusters. Analyse of correlations will be studied. Moreover, we will investigate the interest of the "Paw score" as a prognostic marker and as a correlated parameter.
This is a retrospective study. We want to take information from the year before CT, to the year after CT. At the date of the consultation concomitant with CT we want to know all the clinical, functional and biological data of each patient.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with an age ≥ 40 years and inhalated toxic exposure like Tobacco exposure (present or past, over 10 pack years) and/or professional exposure to a toxic, in presence of obstructive syndrome with a FEV1/FVC ≤ 0.7 after inhalation of a bronchodilatator and measured at stable state (without exacerbation).
Key inclusion criteria (6 listed)
- Age ≥ 40 years
- Inhalated toxic exposure:
- Obstructive syndrome with a FEV1/FVC ≤ 0.7 after inhalation of a bronchodilatator and measured at stable state (without exacerbation)
- Computed tomography performed without injection contrast during common care
Key exclusion criteria (6 listed)
- Patients with an exacerbation within 6 weeks before computed tomography
- Artefacts movements on computed tomography incompatible with quantitative analyse
- Broncho-pulmonary cancer (old or present)
- History of pulmonary surgery
- No follow-up for 1 year after scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phenotypes of Chronic obstructive pulmonary disease (COPD)
Time frame: Day 1
Measure of emphysema
Phenotypes of Chronic obstructive pulmonary disease (COPD)
Time frame: Day 1
Measure of proximal bronchial wall thickness
Phenotypes of Chronic obstructive pulmonary disease (COPD)
Time frame: Day 1
Measure of dimensions of the pulmonary arteries
Phenotypes of Chronic obstructive pulmonary disease (COPD)
Time frame: Day 1
Measure of ratio of main pulmonary artery over aoarta diameter
2 secondary outcomes
Clinical data of survival
Time frame: Day 1
Exacerbations
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
François LAURENT, MD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Bordeaux at 1 site in France.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François LAURENT, MD, PhD (+335 57 65 63 68, francois.laurent@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypes of Chronic obstructive pulmonary disease (COPD) (time frame: Day 1). The study lists 4 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 28 Nov 2017.