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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00472264 |
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Date of registration:
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09/05/2007 |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00472264 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Disease, Chronic Obstructive
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Intervention(s)
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Procedure: PET imaging
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Primary Outcome(s)
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Uptake of FDG (Ki) at <1 and 4 weeks
[Time Frame: <1 and 4 weeks]
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Secondary Outcome(s)
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Airway wall area (as % total airway cross-sectional area) (chest CT assessment, see Appendix 3 for details) (1 week and 4 weeks)
[Time Frame: <1 week and 4 weeks]
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BODE Index (Screening)
[Time Frame: Screening]
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Chronic Respiratory Questionnaire (1week and 4 weeks)
[Time Frame: <1 week and 4 weeks]
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Clinical COPD Questionnaire (Screening 1 week and 4 weeks)
[Time Frame: Screening <1 week and 4 weeks]
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COPD GOLD Stage (screening)
[Time Frame: Screening]
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Emphysema index (chest CT emphysema score) (Screening)
[Time Frame: Screening]
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Lung function indices (FEV1, FVC, FEV1/FVC, DLco) and lung volumes (TLC, IC, RV) (Screening 1 week and 4 weeks)
[Time Frame: screening, <1 week and 4 weeks]
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Smoking history (screening)
[Time Frame: Screening]
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St. George's Respiratory Questionnaire (screening)
[Time Frame: Screening]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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