Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
methodology study, PET Imaging, COPD patients
Brief summary
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.
Detailed description
Single site, eligible subjects enrolled in order of presentation.
Interventions
PROCEDUREPET imaging
Medical imaging assessment
Sponsors
Washington University School of Medicine
Pfizer
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* COPD Patients: * Subjects with a Body Mass Index (BMI) between 18-32 kg/m2. * Patients with a diagnosis, for at least 6 months, of moderate to severe (Stage II - III) COPD as defined by the NIH/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2005 revision), whose disease has been stable for 3 months, and have not had a respiratory tract infection for 6 weeks prior to screening. * Ability to be maintained off inhaled corticosteroids and other anti-inflammatory medications (e.g., theophylline) as required by the protocol * Healthy Volunteers: * Healthy volunteers should be age (+/- 5 years) and gender matched to the COPD subjects * No history of asthma, COPD or other lung disease (including, sarcoidosis, pneumoconiosis, tuberculosis, lung surgery or resection, lung cancer, bronchitis). * Free from clinically significant disease.
Exclusion criteria
* Exacerbation or hospitalisation for COPD within 3 months of screening, or more than twice during the preceding year. * Use of oral corticosteroids in the 6 weeks prior to screen. (Patients who have been taking inhaled corticosteroids as maintenance COPD therapy are eligible provided the dose has remained stable for the previous 6 weeks and it is considered that they could tolerate withdrawal of inhaled corticosteroid for the duration of the study). * A clearly documented history of adult asthma or other chronic respiratory disorders apart from COPD (e.g. clinically significant bronchiectasis, pulmonary fibrosis, pneumoconiosis). * Previous history of bronchial carcinoma, or previous history of lung surgery (including lung resection, pleurodesis, open lung biopsy, video-assisted lung biopsy) or invasive lung procedure (e.g., bronchoscopy (with or without biopsy), bronchoalveolar lavage). * Patients with a history of prior radiation exposure within the past year such that participation this study would put them over 5 rem for annual radiation exposure for research subjects. * History or evidence, based upon a complete medical history, full physical examination, chest X-ray or clinical laboratory test results, of any other significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the subject's safety or the conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uptake of FDG (Ki) at <1 and 4 weeks | <1 and 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Chronic Respiratory Questionnaire (1week and 4 weeks) | <1 week and 4 weeks |
| Emphysema index (chest CT emphysema score) (Screening) | 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 |
| BODE Index (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 |
| COPD GOLD Stage (screening) | Screening |
Countries
United States
Outcome results
None listed