NCT01922180

Brief Summary

To describe Computed Tomography (CT) features associated with severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

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

July 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

2.1 years

First QC Date

August 9, 2013

Last Update Submit

August 13, 2013

Conditions

Keywords

Chest Computed Tomography

Outcome Measures

Primary Outcomes (2)

  • Chest CT scan features at exacerbation

    Grading the severity of the following 15 features: bronchiectasis, mucous plugging, bronchial wall thickening, pulmonary consolidation, ground glass opacity, cysts or bullae, air trapping, centrilobular micronodules, platelike atelectasis, emphysema, pulmonary embolism, pleural effusion, mediastinal or hilar lymphadenopathy, reticular pattern or honeycombing, and pulmonary mass or nodule.

    4 hours

  • Chest CT scan features at control

    Grading the severity of the following 15 features: bronchiectasis, mucous plugging, bronchial wall thickening, pulmonary consolidation, ground glass opacity, cysts or bullae, air trapping, centrilobular micronodules, platelike atelectasis, emphysema, pulmonary embolism, pleural effusion, mediastinal or hilar lymphadenopathy, reticular pattern or honeycombing, and pulmonary mass or nodule.

    Minimum two weeks after exacerbation

Secondary Outcomes (2)

  • PFT at control

    Minimum two weeks after exacerbation

  • PFT at exacerbation

    4 hours

Study Arms (1)

COPD Exacerbation

COPD patients aged 18 years or more, were included at the time of an exacerbation episode leading to admission in our hospital, which corresponds to a severe episode. There were no exclusion criteria. Patients underwent chest CT scans and PFT. After a minimum of two weeks free of any acute symptom after discharge, CT scans and PFT were redone.

Radiation: Chest CT scans

Interventions

CT examinations were performed with a commercially available 64-detector row scanner. Images were acquired in supine position after full inspiration and full expiration, using the following parameters: slice thickness, 0.6 mm; pitch, 1.4; rotation time, 330 msec; tube voltage, 120 kiloVolts; and tube current-time product, 100 milliAmperes, with automatic exposure control (CareDose 4D, Siemens Healthcare) switched on. From raw data, 1-mm-thick section images were reconstructed at 0.7-mm intervals by using a high spatial algorithm and a soft-tissue algorithm. The inspiratory CT scan at the time of exacerbation was performed with intravenous iodinated contrast material, whereas the control scan was unenhanced.

COPD Exacerbation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients followed in our institution (i.e. Erasme University Hospital), who are admitted for a severe exacerbation episode.

You may qualify if:

  • Severe exacerbation episode of COPD, requiring hospital admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme University Hospital

Brussels, Brussels Capital, 1070, Belgium

Location

Related Publications (5)

  • Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.

    PMID: 10843984BACKGROUND
  • Myint PK, Lowe D, Stone RA, Buckingham RJ, Roberts CM. U.K. National COPD Resources and Outcomes Project 2008: patients with chronic obstructive pulmonary disease exacerbations who present with radiological pneumonia have worse outcome compared to those with non-pneumonic chronic obstructive pulmonary disease exacerbations. Respiration. 2011;82(4):320-7. doi: 10.1159/000327203. Epub 2011 May 20.

    PMID: 21597277BACKGROUND
  • Hansell DM, Bankier AA, MacMahon H, McLoud TC, Muller NL, Remy J. Fleischner Society: glossary of terms for thoracic imaging. Radiology. 2008 Mar;246(3):697-722. doi: 10.1148/radiol.2462070712. Epub 2008 Jan 14.

    PMID: 18195376BACKGROUND
  • Rutschmann OT, Cornuz J, Poletti PA, Bridevaux PO, Hugli OW, Qanadli SD, Perrier A. Should pulmonary embolism be suspected in exacerbation of chronic obstructive pulmonary disease? Thorax. 2007 Feb;62(2):121-5. doi: 10.1136/thx.2006.065557. Epub 2006 Nov 13.

    PMID: 17101737BACKGROUND
  • Hackx M, Ghaye B, Coche E, Muylem AV, Gevenois PA. Severe COPD exacerbation: CT features. COPD. 2015 Feb;12(1):38-45. doi: 10.3109/15412555.2014.903916. Epub 2014 Jun 10.

Study Officials

  • Pierre Alain Gevenois, MD, PhD

    Erasme University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 14, 2013

Study Start

July 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations