A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients
NCT00472264
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title | 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 | |||
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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Control Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | 20 Moderate to Severe COPD patients and 8 age- and gender-matched Healthy Volunteer Subjects. | |||
Condition | Pulmonary Disease, Chronic Obstructive | |||
Intervention | Procedure: PET imaging
Medical imaging assessment | |||
Study Groups/Cohorts | 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. Intervention: Procedure: PET imaging | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment | 20 | |||
Original Enrollment | 28 | |||
Actual Study Completion Date | November 2008 | |||
Actual Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 40 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00472264 | |||
Other Study ID Numbers | A9011012 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor | Pfizer | |||
Collaborators | Washington University School of Medicine | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2009 |