AgingNCT01230879
Effect of Ageing on Airway Remodeling
A study testing EFR and TDM in people with Aging, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of the study is to investigate the relationship between aging and morphological changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for this trial. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- EFR and TDM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2009to Aug 2012
- 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 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People from 60 to 95 years old free from chest disease or history of chest disease
Who cannot join
- Chronic cough
- Dyspnea
- Sinonasal or chest infection during enrollment
- Myocardial infarction.
- Current smoker or past smoker with more than 10 pack year intoxication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Bronchoalveolar Lung Remodeling in Subjects From 60 Years Free of Progressive Lung Disease: Structure-function Analysis
The aim of the study is to investigate the relationship between aging and morphological changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for this trial.
Read the detailed description
Chest multidetector CT without injection and spirometry data will be obtained from a multicentric sample of individuals between 60 and 95 years of ageExclusion criteria were current smoking, history of smoking within the past 10 years, any known chronic or acute pulmonary disease. Individuals treated with Amiodarone, Bleomycin or methotrexate were excludedOutcome
- Conditions
- Aging
- Being tested
- EFR and TDM
- Keywords
- Aging lung, Airway remodeling, Airway segmentation, Chest CT
- Medical subject headings
- Airway Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFR and TDMOther
EFR : Pulmonary function test TDM : tomodensitometry
| Study group | Role | What they receive |
|---|---|---|
| 60 - 70 years old | Experimental | EFR and TDM Receives: Other: EFR and TDM |
| 71 - 80 years old | Experimental | EFR and TDM Receives: Other: EFR and TDM |
| 81 - 95 years old | Experimental | EFR and TDM Receives: Other: EFR and TDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchial wall thickness
Bronchial wall thickness and remodeling associated with aging
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study start15 Jul 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BOMMART Sebastien, MD, Principal investigator, University Montpellier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230879
- Sponsor's protocol ID
- 8268
- Status last verified
- Nov 2021
- First submitted
- 4 Aug 2010
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bommart S, Marin G, Bourdin A, Molinari N, Klein F, Hayot M, Vachier I, Chanez P, Mercier J, Vernhet-Kovacsik H. Relationship between CT air trapping criteria and lung function in small airway impairment quantification. BMC Pulm Med. 2014 Feb 28;14:29. doi: 10.1186/1471-2466-14-29.
PubMed 24581147
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bronchoalveolar Lung Remodeling in Subjects From 60 Years Free of Progressive Lung Disease: Structure-function Analysis
- ClinicalTrials.gov ID
- NCT01230879
- Acronym / sponsor ID
- 8268
- Conditions
- Aging
- Keywords
- Aging lung, Airway remodeling, Airway segmentation, Chest CT
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Jul 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Oct 2010 (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.
The aim of the study is to investigate the relationship between aging and morphological changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for this trial.
Detailed description
Chest multidetector CT without injection and spirometry data will be obtained from a multicentric sample of individuals between 60 and 95 years of ageExclusion criteria were current smoking, history of smoking within the past 10 years, any known chronic or acute pulmonary disease. Individuals treated with Amiodarone, Bleomycin or methotrexate were excludedOutcome
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60 - 70 years old | Experimental | Other: EFR and TDMEFR and TDM |
| 71 - 80 years old | Experimental | Other: EFR and TDMEFR and TDM |
| 81 - 95 years old | Experimental | Other: EFR and TDMEFR and TDM |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People from 60 to 95 years old free from chest disease or history of chest disease
Key exclusion criteria (5 listed)
- Chronic cough
- Dyspnea
- Sinonasal or chest infection during enrollment
- Myocardial infarction.
- Current smoker or past smoker with more than 10 pack year intoxication
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 |
|---|---|---|
| EFR and TDMEFR : Pulmonary function test TDM : tomodensitometry | Other | 60 - 70 years old, 71 - 80 years old, 81 - 95 years old |
Primary outcome
Bronchial wall thickness
Time frame: 1 day
Bronchial wall thickness and remodeling associated with aging
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Results publication: PubMed 24581147Bommart S, Marin G, Bourdin A, Molinari N, Klein F, Hayot M, Vachier I, Chanez P, Mercier J, Vernhet-Kovacsik H. Relationship between CT air trapping criteria and lung function in small airway impairment quantification. BMC Pulm Med. 2014 Feb 28;14:29. doi: 10.1186/1471-2466-14-29.
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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.
BOMMART Sebastien, MD principal investigator
University Montpellier Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFR and TDM in people with Aging, run by University Hospital, Montpellier 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 1 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: stopped early, as of the sponsor's last update on 30 Nov 2021. 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 was stopped early. 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?
Bronchial wall thickness (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01230879, which also lists 1 linked publication.
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 30 Nov 2021.