NCT01230879

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

August 4, 2010

Last Update Submit

November 23, 2021

Conditions

Aging

Keywords

Aging lungAirway remodelingAirway segmentationChest CT

Outcome Measures

Primary Outcomes (1)

  • Bronchial wall thickness

    Bronchial wall thickness and remodeling associated with aging

    1 day

Study Arms (3)

60 - 70 years old

EXPERIMENTAL

EFR and TDM

Other: EFR and TDM

71 - 80 years old

EXPERIMENTAL

EFR and TDM

Other: EFR and TDM

81 - 95 years old

EXPERIMENTAL

EFR and TDM

Other: EFR and TDM

Interventions

EFR and TDMOTHER

EFR : Pulmonary function test TDM : tomodensitometry

60 - 70 years old71 - 80 years old81 - 95 years old

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People from 60 to 95 years old free from chest disease or history of chest disease

You may not qualify if:

  • Chronic cough
  • Dyspnea
  • Sinonasal or chest infection during enrollment
  • Myocardial infarction.
  • Current smoker or past smoker with more than 10 pack year intoxication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Montpellier Hospital

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 24581147RESULT

MeSH Terms

Conditions

Airway Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • BOMMART Sebastien, MD

    University Montpellier Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2010

First Posted

October 29, 2010

Study Start

July 15, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations

FR(1)