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

NCT00472264

Last updated date
Study Location
Pfizer Investigational Site
St. Louis, Missouri, 63110, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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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.

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Advanced Information
Descriptive Information
Brief Title A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients
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
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.
Detailed Description Single site, eligible subjects enrolled in order of presentation.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 20 Moderate to Severe COPD patients and 8 age- and gender-matched Healthy Volunteer Subjects.
Condition Pulmonary Disease, Chronic Obstructive
Intervention Procedure: PET imaging
Medical imaging assessment
Study Groups/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.
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 Status Terminated
Actual Enrollment
 (submitted: July 1, 2009)
20
Original Enrollment
 (submitted: May 9, 2007)
28
Actual Study Completion Date November 2008
Actual Primary Completion Date October 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
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00472264
Other Study ID Numbers A9011012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Washington University School of Medicine
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2009