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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192932
• Other study ID #: AK/10-02-13/3863
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: July 3, 2012
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2012
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Airway Remodeling
• COPD
• CT
• Emphysema
• Nycthemeron
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

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

Locations

Country	Name	City	State
Belgium	C.H.U Saint-Pierre	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Erasme University Hospital	Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

Berger P, Perot V, Desbarats P, Tunon-de-Lara JM, Marthan R, Laurent F. Airway wall thickness in cigarette smokers: quantitative thin-section CT assessment. Radiology. 2005 Jun;235(3):1055-64. Epub 2005 Apr 15. — View Citation

Calverley PM, Lee A, Towse L, van Noord J, Witek TJ, Kelsen S. Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease. Thorax. 2003 Oct;58(10):855-60. — View Citation

Hasegawa M, Nasuhara Y, Onodera Y, Makita H, Nagai K, Fuke S, Ito Y, Betsuyaku T, Nishimura M. Airflow limitation and airway dimensions in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1309-15. Epub 2006 Mar 23. — View Citation

Nakano Y, Muro S, Sakai H, Hirai T, Chin K, Tsukino M, Nishimura K, Itoh H, Paré PD, Hogg JC, Mishima M. Computed tomographic measurements of airway dimensions and emphysema in smokers. Correlation with lung function. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1102-8. — View Citation

Orlandi I, Moroni C, Camiciottoli G, Bartolucci M, Pistolesi M, Villari N, Mascalchi M. Chronic obstructive pulmonary disease: thin-section CT measurement of airway wall thickness and lung attenuation. Radiology. 2005 Feb;234(2):604-10. — View Citation

Patel BD, Coxson HO, Pillai SG, Agustí AG, Calverley PM, Donner CF, Make BJ, Müller NL, Rennard SI, Vestbo J, Wouters EF, Hiorns MP, Nakano Y, Camp PG, Nasute Fauerbach PV, Screaton NJ, Campbell EJ, Anderson WH, Paré PD, Levy RD, Lake SL, Silverman EK, Lomas DA; International COPD Genetics Network. Airway wall thickening and emphysema show independent familial aggregation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2008 Sep 1;178(5):500-5. doi: 10.1164/rccm.200801-059OC. Epub 2008 Jun 19. — View Citation

Postma DS, Koëter GH, vd Mark TW, Reig RP, Sluiter HJ. The effects of oral slow-release terbutaline on the circadian variation in spirometry and arterial blood gas levels in patients with chronic airflow obstruction. Chest. 1985 May;87(5):653-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of CT Thorax parameters reflecting emphysema and 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.	4 hours	No
Secondary	Results of pulmonary function tests	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.	4 hours	No