Contact information
Type
Scientific
Primary contact
Prof Myrna Dolovich
ORCID ID
Contact details
1200 Main St West
HSC 1V16
Hamilton
L8N 3Z5
Canada
+1 905 521 2100 ext 73454
mdolovic@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2004HO0826/GSK SCO103387
Study information
Scientific title
Acronym
Study hypothesis
Positron Emission Tomography (PET) is a three-dimensional imaging technique that measures physiological effects including metabolism. 18-fluorodeoxyglucose (18FDG) uptake is a well-validated in vivo measure of tissue glucose metabolism using PET and has been extensively used to monitor the metabolic activity of cells in the brain and to detect tumours. Inflammatory cells utilise glucose as a source of energy during their activation. It is hypothesised that 18FDG uptake by inflammatory cells in the lung could be used as an in vivo measurement of both total and regional lung inflammation.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Chronic Obstructive Pulmonary Disease
Intervention
The study is an observational study, correlating FDG uptake with other parameters that monitor inflammation.
18FDG injection: The subject will receive an intravenous administration of 18FDG of 3 MBq/kg to a maximum of 300 MBq, followed by PET scanning for 90 min.
Intervention type
Drug
Phase
Not Specified
Drug names
18-fluorodeoxyglucose
Primary outcome measures
1. 18FDG uptake in the total lung, right and left lung
2. 18FDG uptake in three pre-defined lung regions (central, intermediate and peripheral) using the computerised shell analysis
Secondary outcome measures
1. Sputum inflammatory cells - Total Cell Count (TCC), Differential Cell Counts (DCC) from induced sputum obtained after 21 minutes nebulised hypertonic saline
2. Spirometry: FEV1, FVC
3. Sputum 18F activity levels post-imaging (COPD only)
Overall trial start date
02/01/2005
Overall trial end date
02/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Inclusion Criteria for Chronic Obstructive Pulmonary Disease (COPD) subjects:
1. Male or Female
2. 40 to 75 years of age
3. COPD, defined as the forced expiratory volume in the first one second to the forced vital capacity of the lungs (FEV1/FVC) being less than 70% that is not fully reversible defined as an increase of less than 15% of predicted FEV1 after inhaling 200 ug salbutamol:
a. mild COPD (Stage I) defined as FEV1 more than 80%, pre-bronchodilator
b. moderate COPD (Stage II) defined as 50% less than FEV1 less than 80%, pre-bronchodilator
c. severe COPD (Stage III) defined as 30% less than FEV1 less than 50%, pre-bronchodilator
4. Current or ex-smokers with more than ten pack year history (i.e. equivalent to 20 cigarettes smoked per day for ten years)
5. Written informed consent
Inclusion Criteria for COPD subjects during an acute exacerbation:
1. Male or Female
2. 40 to 75 years of age
3. Current or ex-smokers with more than ten pack year history (i.e. equivalent to 20 cigarettes smoked per day for ten years)
4. Written informed consent
5. Moderate to severe COPD, defined as FEV1/FVC less than 70% that is not fully reversible defined as an increase of less than 15% of predicted FEV1 after inhaling 200 ug salbutamol:
a. moderate COPD (Stage II) defined as 50% less than FEV1 less than 80%, pre-bronchodilator
b. severe COPD (Stage III) defined as 30% less than FEV1 less than 50%, pre-bronchodilator
6. Acute exacerbation, defined as a worsening of the subject’s condition from the stable state and beyond normal day-to-day variation, which is acute in onset and necessitates a change in regular medication
The subject must have two or three of the following clinical findings:
1. Worsening dyspnea
2. New or increased sputum purulence
3. Increased sputum volume
or one of the above clinical findings plus at least one of the following:
1. Upper respiratory tract infection in the past five days
2. Fever without other apparent cause
3. Increased wheezing
4. Increased cough
5. 20% increase in respiratory rate or heart rate above baseline
Subjects with an acute exacerbation must be within the first two to three days post-presentation of symptoms to be enrolled in the study.
Inclusion Criteria for Healthy Volunteers:
1. Male or Female
2. 40 to 75 years of age
3. Non-smoker
4. Written informed consent
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20 COPD subjects of differing severity and 4 healthy volunteers.
Participant exclusion criteria
Exclusion Criteria for COPD subjects:
1. Other respiratory disorders, including asthma
2. Atopy
3. Other significant disease(s) which may put the subjects at risk or may have influence on the study results
4. Regular use of oxygen therapy
5. Pulmonary exacerbation in the previous four weeks (excluding subjects recruited during an exacerbation of COPD)
6. Received oral prednisone in the previous four weeks
7. Received antibiotics in the previous four weeks
8. Pregnancy or breastfeeding. If in childbearing years, female subjects will be required to provide a negative urine pregnancy test and must be using an acceptable hormonal or barrier contraceptive method to be included in the study. She must be willing to continue to use this type of contraception for the duration of the study
Exclusion Criteria for Healthy Volunteers:
1. History of respiratory disorders, including asthma
2. Atopy
3. Other significant disease(s) which may put the subjects at risk or may have influence on the study results
4. Received oral prednisone in the previous four weeks
5. Respiratory infection or cold in previous four weeks
6. Received antibiotics in the previous four weeks
7. Pregnancy or breastfeeding. If in childbearing years, female subjects will be required to provide a negative urine pregnancy test and must be using an acceptable hormonal or barrier contraceptive method to be included in the study. She must be willing to continue to use this type of contraception for the duration of the study.
Recruitment start date
02/01/2005
Recruitment end date
02/01/2006
Locations
Countries of recruitment
Canada
Trial participating centre
1200 Main St West
Hamilton
L8N 3Z5
Canada
Sponsor information
Organisation
GlaxoSmithKline (Canada)
Sponsor details
7333 Mississauga Road
Mississauga
L5N 6L4
Canada
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
GlaxoSmithKline (Ref No. SCO103387)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary