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A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients

Last updated on March 14, 2019

Study Location
Pfizer Investigational Site
St. Louis, Missouri, 63110 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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,

- 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.

A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients


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