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Effects of Nycthemeral Variations on Computed Tomography (CT) Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent in Chronic Obstructive Pulmonary Disease (COPD)

Effects of Nycthemeral Variations on CT Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent in COPD: Comparisons Between CT Scans Obtained in the Morning and in the Afternoon and Relationships With Pulmonary Function Tests

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01192932
Enrollment
20
Registered
2010-09-01
Start date
2010-03-31
Completion date
2011-06-30
Last updated
2012-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, CT, Nycthemeron

Brief summary

Computed tomography (CT) studies considering bronchial dimensions in chronic obstructive pulmonary disease (COPD) have never considered nycthemeral variations. Airway calibre, in COPD patients, exhibits a nycthemeral variations with maximal values around noon and minimal values in the early morning, that persists under long-acting bronchodilator. Furthermore, no study has assessed the possible nycthemeral variations of CT scans parameters reflecting airway remodelling and emphysema extent in COPD patients. This is a prospective study whose purpose is to assess these variations and their relationships with pulmonary function testing (PFT) in COPD patients.

Detailed description

Patients : COPD patients aged 40 years or more, with a smoking history of \> 10 pack-years (PY), a post-bronchodilator forced expiratory volume in one second to vital capacity ratio (FEV1/VC) \< 0.7 and an optimal treatment according to GOLD guidelines will be included. Exclusion criteria are: COPD exacerbation or respiratory infection in the 4 weeks before the begin of the study, concomitant pulmonary disease (tuberculosis, significant bronchiectasis, lung cancer), pulmonary resection, active malignancy or malignancy of any organ system within the past 5 years. Procedures: All measurements will be performed on the same day, after obtaining the written informed consent of the patient. Medical history, smoking status and patient's treatment will be collected. At 08:00 AM (T0): PFT will be performed, including vital capacity (VC), forced vital capacity (FVC), functional residual capacity (FRC), total lung capacity (TLC), residual volume (RV), forced expiratory volume in one second (FEV1), diffusion lung capacity for carbon monoxide (DLCO), and alveolar volume (VA) measurements (either in absolute values and percentage of predicted values). A first CT scan will be performed using the following technique: * Supine CT scan after full inspiration. * Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length) 90 quality ref mAs with care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm * Reconstructions parameters: B60f 1mm-thick every 0.7 mm, B20f 1mm-thick every 10.0 mm, B35f 1mm-thick every 0.7 mm, B60f 5mm-thick every 5.0 mm and B35f 5mm-thick every 5.0 mm At 04:00 PM (T0+8h): PFT will be performed, including vital capacity (VC), forced vital capacity (FVC), functional residual capacity (FRC), total lung capacity (TLC), residual volume (RV), forced expiratory volume in one second (FEV1), diffusion lung capacity for carbon monoxide (DLCO), and alveolar volume (VA) measurements (either in absolute values and percentage of predicted values). A second CT scan will be performed using the following technique: * Supine CT scan after full inspiration. * Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length) 90 quality ref mAs with care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm * Reconstructions parameters: B60f 1mm-thick every 0.7 mm, B20f 1mm-thick every 10.0 mm, B35f 1mm-thick every 0.7 mm, B60f 5mm-thick every 5.0 mm and B35f 5mm-thick every 5.0 mm Data analysis: * Emphysema index: from B20f reconstructions, calculation of RA960 using Pulmo CT software. * Airway index: from B60f reconstructions (1mm-thick every 0.7 mm), calculations of luminal area and wall area for several bronchi. Statistical analyses : Comparisons of CT parameters values or derived values (for example : wall area to airway area ratio) reflecting emphysema and airways remodelling measured on CT scans obtained à T0 and T0+8h. Correlations with PFT values and derived values.

Interventions

RADIATIONChest CT scan

Supine CT scan after full inspiration. Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length) * 90 quality ref mAs with care-dose ON * 120 kV * Pitch 1.4 * Rotation time 0.33 s * Acquired images 64 x 0.6 mm

Sponsors

Centre Hospitalier Universitaire Saint Pierre
CollaboratorOTHER
Erasme University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age 40 or more * smoking history \> 10 pack-years * post bronchodilator FEV1/VC \< 0.7 * optimal treatment according to GOLD guidelines

Exclusion criteria

* COPD exacerbation or infection in the 4 weeks before the study * concomitant pulmonary disease (tuberculosis, significant bronchiectasis, lung cancer) * pulmonary resection * active malignancy or malignancy of any organ system within the past 5 years

Design outcomes

Primary

MeasureTime frameDescription
Results of CT Thorax parameters reflecting emphysema and airway remodelling4 hoursData analysis: * Emphysema index: from B20f reconstructions, calculation of RA960 using Pulmo CT software. * Airway index: from B60f reconstructions (1mm-thick every 0.7 mm), calculations of luminal area and wall area for several bronchi.

Secondary

MeasureTime frameDescription
Results of pulmonary function tests4 hoursPulmonary function tests will be performed in the morning (T0) and in the afternoon (T0+8h): vital capacity (VC), forced vital capacity (FVC), functional residual capacity (FRC), total lung capacity (TLC), residual volume (RV), forced expiratory volume in one second (FEV1), diffusion lung capacity for carbon monoxide will be measured.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026