NCT02729220

Brief Summary

The purpose of this study is to find out if subjects with chronic obstructive pulmonary disease have signs of accelerated ageing in their airways.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

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

January 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
Last Updated

April 6, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

February 24, 2016

Last Update Submit

April 5, 2016

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

AgingOxidative stressProteasesBronchoscopy

Outcome Measures

Primary Outcomes (4)

  • Cellular senescence marker - Ki67

    Endobronchial mucosal biopsies collected by bronchoscopy. Immunohistochemistry for the cellular senescence markers Ki67 will be performed.

    Baseline

  • Matrix metalloproteinase 12 (MMP12) and the inhibitor TIMP1

    Airway lavages collected by bronchoscopy and serum will be analysed for MMP and TIMP using ELISAs.

    Baseline

  • Levels of oxidized proteins, 4 HNE

    The accumulation of oxidized proteins, 4-Hydroxynonenal, will be assessed in bronchial biopsies.

    Baseline

  • Antioxidant-related transcription factor Nrf2

    Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) is a transcription factor known to be induced by oxidative stress and related to cytoprotection.

    Baseline

Secondary Outcomes (3)

  • Metals in airway lavages

    Baseline

  • Lymphocyte subsets in bronchoalveolar lavage

    Baseline

  • Arterial stiffness

    Baseline

Study Arms (4)

Healthy controls

OTHER

Bronchoscopy with collection of bronchial biopsies and lavages Arterial stiffness

Other: Bronchoscopy

Smokers

OTHER

Bronchoscopy with collection of bronchial biopsies and lavages Arterial stiffness

Other: Bronchoscopy

COPD rapid decline

OTHER

Bronchoscopy with collection of bronchial biopsies and lavages Arterial stiffness

Other: Bronchoscopy

COPD slow decline

OTHER

Bronchoscopy with collection of bronchial biopsies and lavages Arterial stiffness

Other: Bronchoscopy

Interventions

BronchoscopyOTHER

Sampling of airways

COPD rapid declineCOPD slow declineHealthy controlsSmokers

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of COPD, GOLD stage 2-3.
  • Smoking history of at least 10 packyears.

You may not qualify if:

  • Severe ischemic heart disease.
  • Other severe disease.
  • Respiratory infection within four weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health and Clinical Medicine, Division of medicine, Pulmonary medicine

Umeå, Sverige, SE-90185, Sweden

Location

Related Publications (2)

  • Eriksson Strom J, Pourazar J, Linder R, Blomberg A, Lindberg A, Bucht A, Behndig AF. Airway regulatory T cells are decreased in COPD with a rapid decline in lung function. Respir Res. 2020 Dec 14;21(1):330. doi: 10.1186/s12931-020-01593-9.

    PMID: 33317530DERIVED

  • Eriksson Strom J, Pourazar J, Linder R, Blomberg A, Lindberg A, Bucht A, Behndig AF. Cytotoxic lymphocytes in COPD airways: increased NK cells associated with disease, iNKT and NKT-like cells with current smoking. Respir Res. 2018 Dec 7;19(1):244. doi: 10.1186/s12931-018-0940-7.

    PMID: 30526599DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

February 24, 2016

First Posted

April 6, 2016

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Last Updated

April 6, 2016

Record last verified: 2016-03

Locations

SE(1)