Skip to main content
OpenTrials
Completed

NCT Number: NCT01684384

Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.

In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values will be correlated with changes in patient reported outcomes (PROs) and lung function tests recorded at the same time.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital, Edegem, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, ≥ 40 years old
  • COPD as defined by the global Initiative on obstructive lung disease4
  • Post-bronchodilator FEV1/FVC < 70% AND post-bronchodilator FEV1 <80%pred as documented in the last 5 years.
  • Smoking history of at least 10 pack-years
  • At entry in the study experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations, and that necessitates the administration or doubling of systemic corticosteroid treatment.
  • Patients must be able to understand and complete protocol requirements, instructions, questionnaires and protocol-stated restrictions.
  • Written and signed informed consent

Exclusion criteria

  • Pregnant or lactating females
  • Patient diagnosed with asthma
  • Patient with pneumonia as defined radiologically at the start of the exacerbation
  • Patient with a history of or presence of lung cancer
  • Patient with an indication for non-invasive ventilation
  • Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
  • Patient who received any investigational new drug within the last 4 weeks prior to visit 1.

Treatment and study plan

Functional Respiratory Imaging

Radiation

HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.

Other names: HRCT scan

Primary outcomes

  1. Changes in functional respiratory imaging parameters

    Time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)

    The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.

  2. Changes in lung function parameters

    Time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)

    The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.

Secondary outcomes

  1. Changes in patient reported outcome (PRO) measures

    Time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)

    The secondary objective is to check if the changes in CFD data actually correlate better with changes in PRO than changes in lung function parameters.

Other outcomes

  1. Reproducibility of segmentation

    Time frame: Within 1 month of visit

    As tertiary objective the reproducibility of the segmentations done by the centers will be evaluated. To accomplish reproducible segmentations the multiple centers will be guided to perform accurate segmentations, and bottlenecks in the usage of the program will be identified and resolved in order to simplify it where necessary and possible.

Sponsors and collaborators

Lead sponsor

FLUIDDA nv

Industry

Registry information

Official study title

Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2012
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.