HealthyNCT00388765
Normal Control Cohort Sample Bank
An observational study of Healthy, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Nov 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- bronchoscopy, sample bank, research study volunteer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Nizar N Jarjour, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388765
- Sponsor's protocol ID
- H-2006-0240
- Status last verified
- Oct 2008
- First submitted
- 13 Oct 2006
- Last updated
- 5 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol to Establish a Research Sample Bank of Lung Biopsy and BAL Samples for a Non-Atopic, Non-Asthmatic Subject Cohort
- ClinicalTrials.gov ID
- NCT00388765
- Acronym / sponsor ID
- H-2006-0240
- Conditions
- Healthy
- Keywords
- bronchoscopy, sample bank, research study volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 17 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A subject is eligible for participation in the study if all of the following criteria apply:
Key exclusion criteria (8 listed)
- A subject is not eligible to participate in this study if any of the following criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nizar N Jarjour, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.