Evaluation of Airway Gene Expression in COPD and Controlled Populations

NCT00571792 | Terminated

• 1 other identifier: 0406-05-FB
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To explore potential proteins that may be used to develop novel therapies for COPD. This will be accomplished by acquiring material from the lower respiratory tract via endobronchial brushings.

Conditions

COPD

Keywords

COPD

Study Arms (3)

methodologies to identify characteristics of non-smokers with normal lung function

Imaging, genomic and proteomic methodologies to identify characteristics of individuals with normal lung function who do not smoke

methodologies to identify characteristics of smokers but do not demonstrate symptoms of COPD

Imaging, genomic and proteomic methodologies to identify characteristics of individuals who smoke but who do not demonstrate symptoms of chronic obstructive pulmonary disease

methodologies to identify characteristics of smokers that demonstrate symptoms of COPD

Imaging, genomic and proteomic methodologies to identify characteristics of individuals who smoke that demonstrate symptoms of COPD

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males or non-pregnant, non-nursing females who are of non-childbearing potential between the ages of 45 and 70 years of age and who may be either life long non smokers, smokers who do not demonstrate symptoms of COPD and smokers who do demonstrate symptoms of COPD

You may qualify if:

• Age 45-70 yrs of age, incl, women as described above as far as child-bearing potential and subjects who if they have coexisting disease, the disease is stable and does not place an untoward risk or result in compromise of data.
• Non smokers will be lifelong and have not worked in a chronic dusty environment.
• Smokers will require a minimum of 10 pkyr history and currently smoking at least a pack per day. The smokers without symptoms of COPD must demonstrate a pulmonary function with an FEV1 \> 80%. The FEV1/FVC ratio may be less than .7 however they can not demonstrate symptoms of chronic bronchitis by medical history. Smokers with symptoms must demonstrate an FEV1 \< 80% and FEV1/FVC \<.7.

You may not qualify if:

• Any female subject who is pregnant or breast-feeding or a female subject who is of child-bearing potential who is unwilling to sue two acceptable methods of birth control.
• Any condition that would place the subject at risk for endobronchial brushings(such as bleeding diathesis) or subjects who are currently taking anticoagulants.
• Any subject who has had an exacerbation of COPD within the last six months of screening or who has been hospitalized for any reason within the last three months.
• Illicit substances indicated by positive urine drug screen.

Sponsors & Collaborators

• University of Nebraska: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-2465, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Genetic testing involves identification of potential proteins and biomarkers produced from the DNA and RNA analysis. Included are MMP12 and MMP9, Nrf-2 gene, heme oxygenases, glutathione, sythesizing enzymes, thioredoxin reductase, NADPH dependent quinone reductase 1 as well as certain p450 members.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen I Rennard, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: September 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

US (1)