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Study terminated on Nov 7, 2008 as a result of poor recruitment and changes in business priorities. The decision was not based on safety concerns.
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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
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It is hypothesised that there is a difference between the uptake of a radioactive substance ([18F]fluorodeoxyglucose (FDG)) in the lungs of patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy volunteers.
Single site, eligible subjects enrolled in order of presentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study (Healthy volunteers & COPD subjects) | A single arm study PET imaging is carried out twice during the first week of the study and again 4 weeks later in both Healthy volunteers and COPD subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET imaging | Procedure | Medical imaging assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of FDG (Ki) at <1 and 4 weeks | <1 and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BODE Index (Screening) | Screening | |
| Chronic Respiratory Questionnaire (1week and 4 weeks) | <1 week and 4 weeks | |
| Emphysema index (chest CT emphysema score) (Screening) |
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Inclusion Criteria:
Exclusion Criteria:
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20 Moderate to Severe COPD patients and 8 age- and gender-matched Healthy Volunteer Subjects.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Screening |
| Airway wall area (as % total airway cross-sectional area) (chest CT assessment, see Appendix 3 for details) (1 week and 4 weeks) | <1 week and 4 weeks |
| Clinical COPD Questionnaire (Screening 1 week and 4 weeks) | Screening <1 week and 4 weeks |
| COPD GOLD Stage (screening) | Screening |
| Lung function indices (FEV1, FVC, FEV1/FVC, DLco) and lung volumes (TLC, IC, RV) (Screening 1 week and 4 weeks) | screening, <1 week and 4 weeks |
| St. George's Respiratory Questionnaire (screening) | Screening |
| Smoking history (screening) | Screening |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |