Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Normal Control Cohort Sample Bank

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00388765
First received: October 13, 2006
Last updated: October 31, 2008
Last verified: October 2008
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Protocol to Establish a Research Sample Bank of Lung Biopsy and BAL Samples for a Non-Atopic, Non-Asthmatic Subject Cohort

Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment: 10
Study Start Date: September 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Participants in this study must be between the ages of 18 and 45 years and have no general health concerns and do not have allergies or asthma. If qualified, participants will come to the study site up to 3 times over about a 3-week period. This study involves answering questions about your medical history, having a physical exam, urine pregnancy tests for females who might be able to have children, and breathing tests. You will also have a blood draw to test for bleeding problems and an allergy skin test to see if you are allergic to common things. If it is safe for you, you will have a bronchoscopy. A bronchoscopy is a medical procedure to get samples of cells and small pieces of tissue (biopsies) from your lungs.

The study has some risks. The breathing tests may cause you to feel short of breath or dizzy. The allergy skin test will itch and cause a reaction like a mosquito bite.

There are some risks involved with the bronchoscopy. Most people get a sore throat and feel tired after the procedure. You may need to feel a little short of breath. There is a very rare risk of serious problems.

Women are able to join this study only if they are not pregnant or breast-feeding. If you have plans to become pregnant during the time period in which the study takes place, you should not join this study. For women, a urine pregnancy test will be done at the first visit and you will be asked to be on birth control. The study staff can talk to you about the type of birth control that is all right to use in this study.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388765

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
GlaxoSmithKline
Investigators
Principal Investigator: Nizar N Jarjour, MD University of Wisconsin, Madison
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00388765     History of Changes
Other Study ID Numbers: H-2006-0240
Study First Received: October 13, 2006
Last Updated: October 31, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
bronchoscopy
sample bank
research study volunteer

ClinicalTrials.gov processed this record on November 20, 2014