Normal Control Cohort Sample Bank
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | September 2006 |
| End Date: | November 2006 |
Protocol to Establish a Research Sample Bank of Lung Biopsy and BAL Samples for a Non-Atopic, Non-Asthmatic Subject Cohort
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.
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.
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.
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.
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
We found this trial at
1
site
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
Click here to add this to my saved trials
