Condition category
Respiratory
Date applied
02/09/2005
Date assigned
23/08/2006
Last edited
23/08/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.gsk.com

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

Publication citations

Additional files

Editorial Notes