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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00472264
• Other study ID #: A9011012
• Status: Terminated
• Phase: Phase 0
• First received: May 9, 2007
• Last updated: July 1, 2009
• Start date: May 2007
• Est. completion date: November 2008

Study information

• Verified date: July 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Single site, eligible subjects enrolled in order of presentation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• PET imaging
Medical imaging assessment

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of FDG (Ki) at <1 and 4 weeks		<1 and 4 weeks	No
Secondary	BODE Index (Screening)		Screening	No
Secondary	Chronic Respiratory Questionnaire (1week and 4 weeks)		<1 week and 4 weeks	No
Secondary	Emphysema index (chest CT emphysema score) (Screening)		Screening	No
Secondary	Airway wall area (as % total airway cross-sectional area) (chest CT assessment, see Appendix 3 for details) (1 week and 4 weeks)		<1 week and 4 weeks	No
Secondary	Clinical COPD Questionnaire (Screening 1 week and 4 weeks)		Screening <1 week and 4 weeks	No
Secondary	COPD GOLD Stage (screening)		Screening	No
Secondary	Lung function indices (FEV1, FVC, FEV1/FVC, DLco) and lung volumes (TLC, IC, RV) (Screening 1 week and 4 weeks)		screening, <1 week and 4 weeks	No
Secondary	St. George's Respiratory Questionnaire (screening)		Screening	No
Secondary	Smoking history (screening)		Screening	No

External Links

•   To obtain contact information for a study center near you, click here.