An observational study in COPD, CT and Bronchodilation, sponsored by Erasme University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-04.
Sponsored by Erasme University Hospital · Observational
CT studies considering bronchial dimensions in chronic obstructive pulmonary disease (COPD) were conducted without control of bronchodilation. Some data however suggest that total lung capacity (CT scan is performed after full inspiration) is increased in individuals affected by chronic or spontaneous bronchoconstriction and may decrease after bronchodilatation. Furthermore, no study has assessed the effect of bronchodilation on CT scans parameters reflecting airway remodelling and emphysema extent in COPD patients.
This is a prospective study whose purpose is to assess the effect of bronchodilation on lung CT scan and pulmonary function testing (PFT) in COPD patients.
Patients : COPD patients aged 40 years or more, with a smoking history of > 10 pack-years (PY) and a post-bronchodilator forced expiratory volume in one second to vital capacity ratio (FEV1/VC) \< 0.7 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:
At Visit 1, after obtaining the written informed consent of the patient, medical history, smoking status and patient's treatment will be collected. They will be asked to discontinue bronchodilator therapies as follows, such that pulmonary function tests (PFT) and CT scan will be initially evaluated in a medication wash-out period at Visit 2:
At visit 2, 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:
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 B35f 5mm-thick every 5.0 mm
After the initial PFT and CT scan, the patient will receive 80 µg of ipratropium bromide(= 4X20µg Atrovent, via Metered-Dose Inhaler + spacer, 30 seconds between each dose) and 60 minutes later, 400 µg salbutamol (=4X100 µg Ventolin).
A second PFT will be performed 30 min after salbutamol inhalation, followed by a second CT Scan.
Data analysis:
Statistical analyses : Comparisons of CT parameters values or derived values (for example : wall area to airway area ratio) reflecting emphysema and airways remodelling, before and after bronchodilation. Correlations with PFT values and derived values.
187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.
This study's enrollment of 20 is below the median of 74 across 48 observational studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.
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COPD patients aged 40 or more, with a smoking history of > 10 PY and a post-bronchodilator FEV1/VC \< 0.7 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 5y.
Exclusion Criteria:
COPD patients aged 40 or more, with a smoking history of \> 10 PY and a post-bronchodilator FEV1/VC \< 0.7 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 5y.
Radiation: Chest 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
Results of CT Thorax parameters reflecting emphysema airway remodelling
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.
Time frame: 4 hours
Results of pulmonary function tests
Pulmonary function tests will be performed before and after bronchodilation: 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
Time frame: 4 hours
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Erasme University Hospital