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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00472264
Other study ID # A9011012
Secondary ID
Status Terminated
Phase Phase 0
First received May 9, 2007
Last updated July 1, 2009
Start date May 2007
Est. completion date November 2008

Study information

Verified date July 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

Single site, eligible subjects enrolled in order of presentation.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date November 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
PET imaging
Medical imaging assessment

Locations

Country Name City State
United States Pfizer Investigational Site St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Pfizer Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uptake of FDG (Ki) at <1 and 4 weeks <1 and 4 weeks No
Secondary BODE Index (Screening) Screening No
Secondary Chronic Respiratory Questionnaire (1week and 4 weeks) <1 week and 4 weeks No
Secondary Emphysema index (chest CT emphysema score) (Screening) Screening No
Secondary Airway wall area (as % total airway cross-sectional area) (chest CT assessment, see Appendix 3 for details) (1 week and 4 weeks) <1 week and 4 weeks No
Secondary Clinical COPD Questionnaire (Screening 1 week and 4 weeks) Screening <1 week and 4 weeks No
Secondary COPD GOLD Stage (screening) Screening No
Secondary Lung function indices (FEV1, FVC, FEV1/FVC, DLco) and lung volumes (TLC, IC, RV) (Screening 1 week and 4 weeks) screening, <1 week and 4 weeks No
Secondary St. George's Respiratory Questionnaire (screening) Screening No
Secondary Smoking history (screening) Screening No
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