Clinical trial NCT01142531: Effects of Bronchodilation on Computed Tomography (CT) Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent.
Official title: Effects of Bronchodilation on CT Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent: Comparisons Between CT Scans Obtained Before and After Bronchodilation and Relationships With Pulmonary Function Tests.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
CT
Bronchodilation
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Saint Pierre
First posted: 2010-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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:

* Short acting a2 agonists and anticholinergics: 8 wash-out
* Long acting a2 agonists: 12h wash-out
* Long acting anticholinergics: 48h wash-out
* Theophylline preparations: 48h wash-out
* Antileucotrienes: 48h wash-out

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:

* 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 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:

* 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, before and after bronchodilation. Correlations with PFT values and derived values.

Eligibility criteria: Inclusion Criteria:

* age 40 or more
* Smoking history \> 10 pack-years
* post bronchodilator FEV1/VC \< 0.7

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

Primary outcomes:
measure: Results of CT Thorax parameters reflecting emphysema airway remodelling
timeFrame: 4 hours
Secondary outcomes:
measure: Results of pulmonary function tests
timeFrame: 4 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: C.H.U Saint-Pierre
Study officials:
affiliation: Erasme University Hospital
name: Pierre Alain GEVENOIS, MD, PhD
role: STUDY_DIRECTOR
References:
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