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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

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

May 9, 2007
July 1, 2009
May 2007
October 2008   (final data collection date for primary outcome measure)
Uptake of FDG (Ki) at <1 and 4 weeks [ Time Frame: <1 and 4 weeks ] [ Designated as safety issue: No ]
Uptake of FDG (Ki) at <1 and 4 weeks
Complete list of historical versions of study NCT00472264 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1. COPD GOLD Stage (screening)
  • 2. Lung function indices (FEV1, FVC, FEV1/FVC, DLco) and lung volumes (TLC, IC, RV) (Screening 1 week and 4 weeks)
  • 3. St. George’s Respiratory Questionnaire (screening)
  • 4. BODE Index (Screening)
  • 5. Clinical COPD Questionnaire (Screening 1 week and 4 weeks)
  • 6. Chronic Respiratory Questionnaire (1week and 4 weeks)
  • 7. Smoking history (screening)
  • 8. Emphysema index (chest CT emphysema score) (Screening)
  • 9. Airway wall area (as % total airway cross-sectional area) (chest CT assessment, see Appendix 3 for details) (1 week and 4 weeks)
Not Provided
Not Provided
 
A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients
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

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.

Single site, eligible subjects enrolled in order of presentation.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Pulmonary Disease, Chronic Obstructive
Procedure: PET imaging
Medical imaging assessment
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
November 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00472264
A9011012
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Washington University School of Medicine
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP