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Effect of Ageing on Airway Remodeling

Primary Purpose

Aging

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

EFR and TDM

About this trial

This is an interventional diagnostic trial for Aging focused on measuring Aging lung, Airway remodeling, Airway segmentation, Chest CT

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University Montpellier Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

60 - 70 years old

71 - 80 years old

81 - 95 years old

Arm Description

EFR and TDM

Outcomes

Primary Outcome Measures

Bronchial wall thickness

Bronchial wall thickness and remodeling associated with aging

Secondary Outcome Measures

Full Information

NCT ID

NCT01230879

First Posted

August 4, 2010

Last Updated

November 23, 2021

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT01230879

Brief Title

Effect of Ageing on Airway Remodeling

Official Title

Study of Bronchoalveolar Lung Remodeling in Subjects From 60 Years Free of Progressive Lung Disease: Structure-function Analysis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Study Start Date

July 15, 2009 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aging

Keywords

Aging lung, Airway remodeling, Airway segmentation, Chest CT

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

60 - 70 years old

Arm Type

Experimental

Arm Description

EFR and TDM

Arm Title

71 - 80 years old

Arm Type

Experimental

Arm Description

EFR and TDM

Arm Title

81 - 95 years old

Arm Type

Experimental

Arm Description

EFR and TDM

Intervention Type

Other

Intervention Name(s)

EFR and TDM

Intervention Description

EFR : Pulmonary function test TDM : tomodensitometry

Primary Outcome Measure Information:

Title

Bronchial wall thickness

Description

Bronchial wall thickness and remodeling associated with aging

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

BOMMART Sebastien, MD

Organizational Affiliation

University Montpellier Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Montpellier Hospital

City

Montpellier

ZIP/Postal Code

34295

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

24581147

Citation

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.

Results Reference

result

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Effect of Ageing on Airway Remodeling

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