ISRCTN15188976
Completed
Not Applicable
In situ detection of lung inflammation in chronic obstructive pulmonary disease using 18-fluorodeoxyglucose and positron emission tomography
GlaxoSmithKline (Canada)0 sites24 target enrollmentAugust 23, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline (Canada)
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
Exclusion Criteria
- •Exclusion Criteria for COPD subjects:
- •1\. Other respiratory disorders, including asthma
- •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
Outcomes
Primary Outcomes
Not specified
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