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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01204970
Other study ID # B32220109292
Secondary ID
Status Completed
Phase N/A
First received September 17, 2010
Last updated December 29, 2016
Start date September 2010
Est. completion date December 2016

Study information

Verified date December 2016
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date December 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium University Hospitals Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary morphometry morpohometrical analysis at different time point after lung transplantation 90 - 180 - 360 - 540 - 720 days No
Secondary adverse events bleeding, pneumothorax, pleuritic chest pain during procedure 90 - 180 - 360- 540- 720 days Yes
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