BronchiectasisBRONCOCANCT02804971
Cardiovascular Comorbidities and Bronchiectasis
An observational study of Bronchiectasis, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with inflammation, which leads to a progressive lung deterioration. This disease is responsible for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of hospitalization. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Bronchiectasis
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2016to 31 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of bronchiectasis based on imaging in a recent (less than 2 years) CT-scan.
Who may be able to join
- 40 ≤ Age ≤ 80 years
- Formal diagnosis of bronchiectasis by imaging (CT-scan)
- For women, pregnancy test negative
- Affiliation to a social Security
- written inform consent
Who cannot join
- Patients with a diagnosis of Cystic Fibrosis
- Contre indication of one of the tests
- Exacerbation with hospitalization or outpatient clinic visit in the last 4 weeks.
- Unability to obtain an informed consent
- Pregnancy or Breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis
Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with inflammation, which leads to a progressive lung deterioration. This disease is responsible for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of hospitalization. Natural history is marked by recurrent infectious diseases which are the main prognosis factor. This disease is associated with an inflammation rate in the lung as well as in the blood. Up to now, no study has been described comorbidities associated with this chronic disease but our hypothesis is that cardiovascular diseases will be more frequent in these patients. In fact systemic inflammation driven by bronchial infections may increase frequency of cardiovascular diseases.
The investigators decide to conduct a monocentric observational study to define the prevalence and characterization of cardiovascular comorbidities as well as markers of accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities are frequent in bronchiectasis and may be associated with markers of inflammation and aging.
Read more
Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed.
Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations.
Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed.
Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.
Read the detailed description
Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed.
Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations.
Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed.
Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.
- Conditions
- Bronchiectasis
- Medical subject headings
- Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of the cardiovascular comorbidities
Measured: Examinations / tests required for this primary outcome measure will be performed within the month following the inclusion visit.
Secondary outcomes (3)
Frequency of aging-related abnormalities (higher aortic pulse-wave velocity, lower bone mineral density, lower squelettal muscle mass index) and shorter telomere length in patients.
Measured: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
Correlation between the severity of the disease (BSI score) and cardiovascular comorbidities.
Measured: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
Correlation between biological markers of aging and inflammation.
Measured: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start25 Oct 2016
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard MAITRE, Principal investigator, CHI Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804971
- Sponsor's protocol ID
- BRONCOCA
- Acronym
- BRONCOCA
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2016
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis
- ClinicalTrials.gov ID
- NCT02804971
- Acronym / sponsor ID
- BRONCOCA / BRONCOCA
- Conditions
- Bronchiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Jun 2016 (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.
Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with inflammation, which leads to a progressive lung deterioration. This disease is responsible for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of hospitalization. Natural history is marked by recurrent infectious diseases which are the main prognosis factor. This disease is associated with an inflammation rate in the lung as well as in the blood. Up to now, no study has been described comorbidities associated with this chronic disease but our hypothesis is that cardiovascular diseases will be more frequent in these patients. In fact systemic inflammation driven by bronchial infections may increase frequency of cardiovascular diseases.
The investigators decide to conduct a monocentric observational study to define the prevalence and characterization of cardiovascular comorbidities as well as markers of accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities are frequent in bronchiectasis and may be associated with markers of inflammation and aging.
Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed.
Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations.
Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed.
Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.
Detailed description
Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed.
Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations.
Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed.
Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of bronchiectasis based on imaging in a recent (less than 2 years) CT-scan.
Key inclusion criteria (5 listed)
- 40 ≤ Age ≤ 80 years
- Formal diagnosis of bronchiectasis by imaging (CT-scan)
- For women, pregnancy test negative
- Affiliation to a social Security
- written inform consent
Key exclusion criteria (5 listed)
- Patients with a diagnosis of Cystic Fibrosis
- Contre indication of one of the tests
- Exacerbation with hospitalization or outpatient clinic visit in the last 4 weeks.
- Unability to obtain an informed consent
- Pregnancy or Breast feeding
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
Frequency of the cardiovascular comorbidities
Time frame: Examinations / tests required for this primary outcome measure will be performed within the month following the inclusion visit.
3 secondary outcomes
Frequency of aging-related abnormalities (higher aortic pulse-wave velocity, lower bone mineral density, lower squelettal muscle mass index) and shorter telomere length in patients.
Time frame: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
Correlation between the severity of the disease (BSI score) and cardiovascular comorbidities.
Time frame: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
Correlation between biological markers of aging and inflammation.
Time frame: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
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 29 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Bronchiectasis
RecruitingPhase 2
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
Bronchiectasis, Sleep-Disordered Breathing
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Active, not recruitingObservational study
Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
Cystic Fibrosis (CF), Non Cystic Fibrosis Bronchiectasis
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.
Bernard MAITRE principal investigator
CHI Créteil
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 Bronchiectasis, run by Centre Hospitalier Intercommunal Creteil 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 5 inclusion and 5 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 29 Jun 2026. 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?
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?
Frequency of the cardiovascular comorbidities (time frame: Examinations / tests required for this primary outcome measure will be performed within the month following the inclusion visit.). 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 29 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.