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TerminatedNCT00472264Updated Jul 2, 2009

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

An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Pfizer. Terminated at 1 site in United States. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-02.

Sponsored by Pfizer · Observational

Why this study was 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.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Single site, eligible subjects enrolled in order of presentation.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • methodology study, PET Imaging, COPD patients
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In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 20 is below the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)

Groups and cohorts

  • 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

Interventions

  • ProcedurePET imaging

    Medical imaging assessment

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What researchers measure

Primary outcomes

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

    Time frame: <1 and 4 weeks

Secondary outcomes

  1. BODE Index (Screening)

    Time frame: Screening

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

    Time frame: <1 week and 4 weeks

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

    Time frame: Screening

  4. 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

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

    Time frame: Screening <1 week and 4 weeks

  6. COPD GOLD Stage (screening)

    Time frame: Screening

  7. 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

  8. St. George's Respiratory Questionnaire (screening)

    Time frame: Screening

  9. Smoking history (screening)

    Time frame: Screening

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Study locations

1 site
  • Pfizer Investigational Site
    St. Louis, Missouri 63110, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00472264
Lead sponsor
Pfizer
Collaborators
Washington University School of Medicine
First posted
May 11, 2007
Start date
May 2007
Primary completion
Oct 2008
Completion
Nov 2008
Last update
Jul 2, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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