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

Stopped early

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00472264

Run by

Pfizer

People needed

20

Starts

2007-05-01

Expected to finish

2008-11-01

Last updated by the study team

2009-07-02

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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