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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

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NCT00472264

Last updated on November 11, 2019
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
St. Louis, Missouri, 63110 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00472264
Pfizer
Terminated
A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients

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Descriptive Information
Brief TitleA Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients
Official TitleAn 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
Brief SummaryIt 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.
Detailed DescriptionSingle site, eligible subjects enrolled in order of presentation.
Study TypeObservational
Study DesignObservational Model: Case Control
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Population20 Moderate to Severe COPD patients and 8 age- and gender-matched Healthy Volunteer Subjects.
ConditionPulmonary Disease, Chronic Obstructive
InterventionProcedure: PET imaging
Medical imaging assessment
Study Groups/CohortsSingle 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
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusTerminated
Actual Enrollment
 (submitted: July 1, 2009)		20
Original Enrollment
 (submitted: May 9, 2007)		28
Actual Study Completion DateNovember 2008
Actual Primary Completion DateOctober 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00472264
Other Study ID NumbersA9011012
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsWashington University School of Medicine
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2009

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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