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Trial record 19 of 734 for:    lung transplant

Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Marc Decramer, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01204970
First received: September 17, 2010
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive pulmonary disease (COPD) and lung transplant recipients is described and will be correlated with clinical findings in order to described small airway remodelling in these patients.


Condition
Lung Transplantation
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Confocal Laser Micro-endoscopy: New Insights in COPD and Lung Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • morphometry [ Time Frame: 90 - 180 - 360 - 540 - 720 days ] [ Designated as safety issue: No ]
    morpohometrical analysis at different time point after lung transplantation


Secondary Outcome Measures:
  • adverse events [ Time Frame: 90 - 180 - 360- 540- 720 days ] [ Designated as safety issue: Yes ]
    bleeding, pneumothorax, pleuritic chest pain during procedure


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD
COPD Gold class 1-4
Transplant
Lung transplant recipients
Control
Patients with normal spirometric data

Detailed Description:

In early phases of COPD, changes in small airway characteristics may develop. Elastin decay and matrix remodelling could be responsible for these changes. Using CLME changes of in the bronchiolar wall and alveolar ducts can be visualized, described and measured.

In lung transplant recipients, CMLE will be performed to distinguish characteristics of distal airways in stabile patient in contrast to patients with bronchiolitis obliterans syndrome.

In both groups data will be correlated with CT findings, pulmonary function tests and anatomopathological results.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients referred for a bronchoscopic procedure will be asked to undergo CLME. 3 pools will be made: COPD patients according to their pulmonary function test, lung transplant recipients and patients with normal spirometric results. In all groups the difference between active smokers and no-smokers will be made.

Criteria

Inclusion Criteria:

  • referral for bronchoscopic investigation/sampling
  • informed consent signed
  • recent spirometric data

Exclusion Criteria:

  • sedated and/or ventilated patients
  • patients on ICU
  • patients under oral anticoagulation
  • co-existing lung disease
  • acute infectious pulmonary disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204970

Contacts
Contact: Jonas Yserbyt, MD +3216340442 jonas.yserbyt@uzleuven.be
Contact: Christophe Dooms, PhD +3216332211 christophe.dooms@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: jonas Yserbyt, MD    +3216340442    jonas.yserbyt@uzleuven.be   
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Jonas Yserbyt, MD University Hospitals Leuven
Principal Investigator: Chistophe Dooms, MD, PhD University Hospitals Leuven
Study Chair: Marc Decramer, MD, PhD University Hospitals Leuven
Study Chair: Geert Verleden, Md, PhD University Hospitals Leuven
Study Chair: Wim Janssens, MD, PhD University Hospitals Leuven
  More Information

No publications provided

Responsible Party: Marc Decramer, Prof. Dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01204970     History of Changes
Other Study ID Numbers: B32220109292
Study First Received: September 17, 2010
Last Updated: August 5, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:
Confocal Laser Scanning Microendoscopy
Small airways
COPD
Lung transplantation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014