NCT02873988

Brief Summary

Airway epithelium integrity is essential to maintain its role of mechanical and functional barrier. Recurrent epithelial injuries require a complex mechanism of repair to restore its integrity. In chronic obstructive pulmonary disease (COPD), an abnormal airway epithelial repair may participate in airway remodelling. The objective was to determine if airway epithelial wound repair of airway epithelium is abnormal in COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

August 10, 2016

Last Update Submit

August 16, 2016

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Mean speed of wound closure (MSWC) of wounded bronchial epithelial cell culture obtained from COPD and control patients

    hour 18

Secondary Outcomes (4)

  • Cell proliferation index in supernatants of bronchial epithelial cells 18 hours after cell wounding.

    hour 18

  • Matrix metalloprotease (MMP)-2 level in supernatants of bronchial epithelial cells 18 hours after cell wounding.

    hour 18

  • Matrix metalloprotease (MMP)-9 level in supernatants of bronchial epithelial cells 18 hours after cell wounding.

    hour 18

  • Cytokines levels in supernatants of bronchial epithelial cells 18 hours after cell wounding.

    hour 18

Study Arms (2)

patients with COPD

patients with COPD

Other: bronchial epithelial cell culture

patients without COPD

patients without COPD

Other: bronchial epithelial cell culture

Interventions

bronchial epithelial cell cultureOTHER
patients with COPDpatients without COPD

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for lung resection for cancer

You may qualify if:

  • Patients scheduled for lung resection for cancer

You may not qualify if:

  • Patients with asthma, cystic fibrosis, bronchiectasis or pulmonary fibrosis were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

Related Publications (1)

  • Perotin JM, Adam D, Vella-Boucaud J, Delepine G, Sandu S, Jonvel AC, Prevost A, Berthiot G, Pison C, Lebargy F, Birembaut P, Coraux C, Deslee G. Delay of airway epithelial wound repair in COPD is associated with airflow obstruction severity. Respir Res. 2014 Nov 27;15(1):151. doi: 10.1186/s12931-014-0151-9.

    PMID: 25427655BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 22, 2016

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

August 22, 2016

Record last verified: 2016-08

Locations

FR(1)