- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01230879
Effect of Ageing on Airway Remodeling
November 23, 2021 updated by: University Hospital, Montpellier
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- University Montpellier Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- People from 60 to 95 years old free from chest disease or history of chest disease
Exclusion Criteria:
- Chronic cough
- Dyspnea
- Sinonasal or chest infection during enrollment
- Myocardial infarction.
- Current smoker or past smoker with more than 10 pack year intoxication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 60 - 70 years old
EFR and TDM
|
EFR : Pulmonary function test TDM : tomodensitometry
|
|
Experimental: 71 - 80 years old
EFR and TDM
|
EFR : Pulmonary function test TDM : tomodensitometry
|
|
Experimental: 81 - 95 years old
EFR and TDM
|
EFR : Pulmonary function test TDM : tomodensitometry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bronchial wall thickness
Time Frame: 1 day
|
Bronchial wall thickness and remodeling associated with aging
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: BOMMART Sebastien, MD, University Montpellier Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 15, 2009
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 4, 2010
First Submitted That Met QC Criteria
October 28, 2010
First Posted (Estimate)
October 29, 2010
Study Record Updates
Last Update Posted (Actual)
November 30, 2021
Last Update Submitted That Met QC Criteria
November 23, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8268
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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