NCT02092675

Brief Summary

The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

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, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

March 17, 2014

Last Update Submit

December 22, 2014

Conditions

Chronic Obstructive Pulmonary DiseaseEndothelial Dysfunction

Keywords

Chronic obstructive pulmonary diseasefrequent exacerbatorendothelial dysfunctionFlow mediated dilatationSystemic inflammation

Outcome Measures

Primary Outcomes (1)

  • difference in endothelial dysfunction

    Evidence of difference in endothelial dysfunction between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group

    6 months

Secondary Outcomes (1)

  • difference in pulmonary functional tests

    6 months

Other Outcomes (1)

  • difference in systemic inflammation

    6 months

Study Arms (3)

COPD patients - frequent exacerbator

COPD patients with 2 and more exacerbation in one year

COPD patients - non frequent exacerbator

COPD patients with less than 2 exacerbation during one year

control group - healthy smokers

healthy smokers, they do not have COPD

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with COPD, smokers and former smokers recruited in an ambulatory basis.

You may qualify if:

  • COPD patients in stable condition ( without exacerbation min 1 months ago)
  • Over 40 years
  • History of at least 10 py

You may not qualify if:

  • acute exacerbation of COPD
  • active malignancy
  • autoimmune disease
  • acute myocardial infarction
  • diabetes mellitus with late complications
  • congestive heart failure
  • women of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerity Hospital Centre Zagreb

Zagreb, Croatia, 10000, Croatia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Andrea Vukic Dugac

    University Hospital Zagreb

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
pulmonary disease specialist

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 20, 2014

Study Start

March 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 24, 2014

Record last verified: 2014-12

Locations

CR(1)