Clinical trial NCT00472264: A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients
Official title: An Exploratory Study To Investigate The Reproducibility Of Lung 18Fluoro-Deoxyglucose Positron Emission Tomography In Patients With Chronic Obstructive Airways Disease (COPD) In The Absence Of Anti-Inflammatory Treatments
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: methodology study, PET Imaging, COPD patients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Washington University School of Medicine
First posted: 2007-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 Moderate to Severe COPD patients and 8 age- and gender-matched Healthy Volunteer Subjects.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Uptake of FDG (Ki) at <1 and 4 weeks
timeFrame: <1 and 4 weeks
Secondary outcomes:
measure: BODE Index (Screening)
timeFrame: Screening
measure: Chronic Respiratory Questionnaire (1week and 4 weeks)
timeFrame: <1 week and 4 weeks
measure: Emphysema index (chest CT emphysema score) (Screening)
timeFrame: Screening
measure: Airway wall area (as % total airway cross-sectional area) (chest CT assessment, see Appendix 3 for details) (1 week and 4 weeks)
timeFrame: <1 week and 4 weeks
measure: Clinical COPD Questionnaire (Screening 1 week and 4 weeks)
timeFrame: Screening <1 week and 4 weeks
measure: COPD GOLD Stage (screening)
timeFrame: Screening
measure: Lung function indices (FEV1, FVC, FEV1/FVC, DLco) and lung volumes (TLC, IC, RV) (Screening 1 week and 4 weeks)
timeFrame: screening, <1 week and 4 weeks
measure: St. George's Respiratory Questionnaire (screening)
timeFrame: Screening
measure: Smoking history (screening)
timeFrame: Screening
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: