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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

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00472264
Collaborator
Washington University School of Medicine (Other)
20
Enrollment
1
Location
18.1
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PET imaging

Detailed Description

Single site, eligible subjects enrolled in order of presentation.

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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 Start Date :
May 1, 2007
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: PET imaging
Medical imaging assessment

Outcome Measures

Primary Outcome Measures

  1. Uptake of FDG (Ki) at <1 and 4 weeks [<1 and 4 weeks]

Secondary Outcome Measures

  1. BODE Index (Screening) [Screening]

  2. Chronic Respiratory Questionnaire (1week and 4 weeks) [<1 week and 4 weeks]

  3. Emphysema index (chest CT emphysema score) (Screening) [Screening]

  4. 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]

  5. Clinical COPD Questionnaire (Screening 1 week and 4 weeks) [Screening <1 week and 4 weeks]

  6. COPD GOLD Stage (screening) [Screening]

  7. 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]

  8. St. George's Respiratory Questionnaire (screening) [Screening]

  9. Smoking history (screening) [Screening]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 -

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site St. Louis Missouri United States 63110

Sponsors and Collaborators

  • Pfizer
  • Washington University School of Medicine

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00472264
Other Study ID Numbers:
  • A9011012
First Posted:
May 11, 2007
Last Update Posted:
Jul 2, 2009
Last Verified:
Jul 1, 2009
Keywords provided by , ,
methodology study, PET Imaging, COPD patients
Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jul 2, 2009