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

NCT01192932 | Completed

• 1 other identifier: AK/10-02-13/3863
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; CT; Nycthemeron

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Results of pulmonary function tests

  4 hours

Study Arms (1)

COPD

COPD patients aged 40 or more, with a smoking history of \> 10 pack-years, a post-bronchodilator 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.

Radiation: Chest CT scan

Interventions

Chest CT scan RADIATION

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

COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients aged 40 or more, with a smoking history of \> 10 PY, a post-bronchodilator 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.

You may qualify if:

• age 40 or more
• smoking history \> 10 pack-years
• post bronchodilator FEV1/VC \< 0.7
• optimal treatment according to GOLD guidelines

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead
• Centre Hospitalier Universitaire Saint Pierre: collaborator

Study Sites (1)

C.H.U Saint-Pierre

Brussels, 1000, Belgium

Location

Related Publications (7)

• Nakano Y, Muro S, Sakai H, Hirai T, Chin K, Tsukino M, Nishimura K, Itoh H, Pare 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. doi: 10.1164/ajrccm.162.3.9907120.

  PMID: 10988137 BACKGROUND

• 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. doi: 10.1164/rccm.200601-037OC. Epub 2006 Mar 23.

  PMID: 16556695 BACKGROUND

• Patel BD, Coxson HO, Pillai SG, Agusti AG, Calverley PM, Donner CF, Make BJ, Muller NL, Rennard SI, Vestbo J, Wouters EF, Hiorns MP, Nakano Y, Camp PG, Nasute Fauerbach PV, Screaton NJ, Campbell EJ, Anderson WH, Pare 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.

  PMID: 18565956 BACKGROUND

• 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. doi: 10.1148/radiol.2353040121. Epub 2005 Apr 15.

  PMID: 15833982 BACKGROUND

• 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. doi: 10.1148/radiol.2342040013.

  PMID: 15671010 BACKGROUND

• Postma DS, Koeter 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. doi: 10.1378/chest.87.5.653.

  PMID: 3987377 BACKGROUND

• 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. doi: 10.1136/thorax.58.10.855.

  PMID: 14514937 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Alain GEVENOIS, MD, PhD

  Erasme University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maxime HACKX, MD

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 1, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 4, 2012

Record last verified: 2012-07

Locations

BE (1)