C.H.U Saint-Pierre
Brussels, 1000, Belgium
NCT Number: NCT01192932
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.
Looking for future studies?
Notify Me40 year and older
All sexes
Observational
Brussels, 1000, Belgium
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:
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:
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 measured on CT scans obtained à T0 and T0+8h. Correlations with PFT values and derived values.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supine CT scan after full inspiration. Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length)
Time frame: 4 hours
Data analysis:
Time frame: 4 hours
Pulmonary 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.
Erasme University Hospital
Other
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
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.
NCT01142531
Bronchodilation, COPD
Brussels, Belgium
View Trial DetailsNCT03927820
Asthma, Bronchial Diseases
Nashville, Tennessee, United States
View Trial DetailsNCT06614959
Bronchial Diseases, Bronchitis
Montreal, Quebec, Canada
View Trial DetailsNCT04754490
COPD, Chronic Disease
Abercynon, Wales, United Kingdom
View Trial Details