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Effects of Bronchodilation on Computed Tomography (CT) Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent.

This study has been completed.
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Saint Pierre
Information provided by (Responsible Party):
Maxime HACKX, Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT01142531
First received: April 12, 2010
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
COPD
CT
Bronchodilation
Radiation: Chest CT scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • Results of CT Thorax parameters reflecting emphysema airway remodelling [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Results of pulmonary function tests [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

    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



Enrollment: 20
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
COPD
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142531

Locations
Belgium
C.H.U Saint-Pierre
Brussels, Belgium, 1000
Sponsors and Collaborators
Erasme University Hospital
Centre Hospitalier Universitaire Saint Pierre
Investigators
Study Director: Pierre Alain GEVENOIS, MD, PhD Erasme University Hospital
  More Information

Publications:

Responsible Party: Maxime HACKX, Maxime HACKX, MD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT01142531     History of Changes
Other Study ID Numbers: AK/10-02-13/3862
Study First Received: April 12, 2010
Last Updated: July 3, 2012
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Additional relevant MeSH terms:
Airway Remodeling
Emphysema
Pulmonary Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Pathological Conditions, Anatomical
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014