Normal Control Cohort Sample Bank

NCT ID: NCT00388765

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2006-11-30

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.

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.

Conditions

Healthy

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nizar N Jarjour, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

H-2006-0240

Identifier Type: -

Identifier Source: org_study_id