Normal Control Cohort Sample Bank
Protocol to Establish a Research Sample Bank of Lung Biopsy and BAL Samples for a Non-Atopic, Non-Asthmatic Subject Cohort
1 other identifier
observational
10
1 country
1
Brief Summary
This study is designed to collect lung washing samples and small pieces of tissue (biopsies) from the lungs of people who do not have any allergies or asthma. These samples will be used by researchers in the future as control samples to compare to samples from people with chronic lung diseases such as allergic asthma or emphysema. Control samples are samples are very important in laboratory experiments so that the researchers can tell what may be labeled as different or abnormal in samples from people with lung disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2006
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 13, 2006
CompletedFirst Posted
Study publicly available on registry
October 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedOctober 5, 2015
October 1, 2008
2 months
October 13, 2006
October 1, 2015
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- A subject is eligible for participation in the study if all of the following criteria apply:
- Ability to give a valid informed consent to participate by signing and dating a written consent form.
- Male or female with no chronic or acute health concerns that might affect subject safety during the study or interfere with the study results, 18-45 years of age
- An FEV1 \> 80% of predicted with an FEV1/FVC ratio above 0.70
- Methacholine PC20 \>16 mg/ml
- Skin test negative to panel of 12 common aeroallergens
You may not qualify if:
- A subject is not eligible to participate in this study if any of the following criteria apply:
- Medications other than for contraception or OTC pain medications to be approved by PI
- Recent smoker (within 5 years) or has a smoking history exceeding 5 pack years
- Currently participating in another clinical trial or has participated in an investigational drug trial with in one month of the screening visit
- Unable, in the judgment of the investigator, to comply with directions and/or tolerate the procedures required for participation in this trial,
- Pregnant or breast-feeding or has a planned pregnancy during the course of the study
- History of bleeding with trauma or abnormal clotting tests
- History of allergy to any of the medications/sedatives that may be administered during the bronchoscopy procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- GlaxoSmithKlinecollaborator
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53792, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Nizar N Jarjour, MD
University of Wisconsin, Madison
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2006
First Posted
October 17, 2006
Study Start
September 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
October 5, 2015
Record last verified: 2008-10