COPDNCT01192932
Effects of Nycthemeral Variations on Computed Tomography (CT) Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent in Chronic Obstructive Pulmonary Disease (COPD)
An observational study of COPD and CT, run by Erasme University Hospital at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, CT, Nycthemeron
- What is being tested?
- Chest CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age 40 or more
- smoking history > 10 pack-years
- post bronchodilator FEV1/VC < 0.7
- optimal treatment according to GOLD guidelines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- COPD, CT, Nycthemeron
- Being tested
- Chest CT scan
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CT scanRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Chest CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Secondary outcomes (1)
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Saint Pierre
- Responsible party
- Principal investigator, Maxime HACKX, Erasme University Hospital
- Investigators
- Pierre Alain GEVENOIS, MD, PhD, Study director, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192932
- Sponsor's protocol ID
- AK/10-02-13/3863
- Status last verified
- Jul 2012
- First submitted
- 31 Aug 2010
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10988137Hasegawa 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.
PubMed 16556695Patel 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.
PubMed 18565956Berger 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.
PubMed 15833982Orlandi 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.
PubMed 15671010Postma 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.
PubMed 3987377Calverley 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.
PubMed 14514937
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01192932
- Acronym / sponsor ID
- AK/10-02-13/3863
- Conditions
- COPD, CT, Nycthemeron
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Saint Pierre
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Radiation: Chest CT scanCOPD 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- age 40 or more
- smoking history > 10 pack-years
- post bronchodilator FEV1/VC < 0.7
- optimal treatment according to GOLD guidelines
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest CT scanSupine 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 | Radiation | COPD |
Primary outcome
Results of CT Thorax parameters reflecting emphysema and airway remodelling
Time frame: 4 hours
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.
1 secondary outcome
Results of pulmonary function tests
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
- Background: PubMed 10988137Nakano 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.
- Background: PubMed 16556695Hasegawa 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.
- Background: PubMed 18565956Patel 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.
- Background: PubMed 15833982Berger 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.
- Background: PubMed 15671010Orlandi 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.
- Background: PubMed 3987377Postma 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.
- Background: PubMed 14514937Calverley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Alain GEVENOIS, MD, PhD study director
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and CT, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of CT Thorax parameters reflecting emphysema and airway remodelling (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192932, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2012.