A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients

This study has been terminated.
(Study terminated on Nov 7, 2008 as a result of poor recruitment and changes in business priorities. The decision was not based on safety concerns.)
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00472264
First received: May 9, 2007
Last updated: July 1, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Procedure: PET imaging
Phase 0

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Uptake of FDG (Ki) at <1 and 4 weeks [ Time Frame: <1 and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BODE Index (Screening) [ Time Frame: Screening ] [ Designated as safety issue: No ]
  • Chronic Respiratory Questionnaire (1week and 4 weeks) [ Time Frame: <1 week and 4 weeks ] [ Designated as safety issue: No ]
  • Emphysema index (chest CT emphysema score) (Screening) [ Time Frame: Screening ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical COPD Questionnaire (Screening 1 week and 4 weeks) [ Time Frame: Screening <1 week and 4 weeks ] [ Designated as safety issue: No ]
  • COPD GOLD Stage (screening) [ Time Frame: Screening ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • St. George's Respiratory Questionnaire (screening) [ Time Frame: Screening ] [ Designated as safety issue: No ]
  • Smoking history (screening) [ Time Frame: Screening ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

Single site, eligible subjects enrolled in order of presentation.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

20 Moderate to Severe COPD patients and 8 age- and gender-matched Healthy Volunteer Subjects.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472264

Locations
United States, Missouri
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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00472264     History of Changes
Other Study ID Numbers: A9011012
Study First Received: May 9, 2007
Last Updated: July 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
methodology study, PET Imaging, COPD patients

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014