Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001541
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Analysis of Bronchial Tissue and Fluid in Patients With Wegeners Granulomatosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Analysis of Bronchial and Bronchoalveolar Lavage Fluid and Bronchial Mucosal Biopsies in Patients With Wegeners Granulomatosis
Status:
COMPLETED
Status Verified Date:
2003-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will collect fluid and tissue samples from the bronchi air passages to the lungs of patients with Wegeners granulomatosis for laboratory examination Wegeners granulomatosis is a type of vasculitis blood vessel inflammation that can affect many parts of the body including the brain nerves eyes skin sinuses kidneys intestinal tract joints heart lungs and other sites About 85 percent of patients have lung involvement The lining of the bronchi bronchial mucosa is composed of cells that produce mucus inflammatory cells and inflammatory mediators chemicals produced in response to inflammation Analysis of these various substances may provide insight into what causes different types of lung problems in Wegeners granulomatosis
Patients between 18 and 75 years of age with Wegeners granulomatosis who require bronchoscopy to evaluate the cause of their lung problem may be eligible for this study
Participants will undergo a bronchoscopy in the hospital intensive care unit ICU For this procedure the mouth and throat are numbed with lidocaine jelly and spray If needed a sedative is given for comfort A small plastic tube intravenous catheter is placed in a vein to give medications A pencil-thin tube is then placed through the nose or mouth into the lung airways to examine the airways carefully
At the time of the bronchoscopy patients in this study will undergo the following additional procedures
Bronchoalveolar lavage - Saline salt water is injected through the bronchoscope into the air passage acting as a rinse A sample of the fluid is then withdrawn and examined for infection inflammatory cells and inflammatory chemicals This may be done as part of the standard medical care procedure
Bronchial lavage - This procedure is similar to bronchoalveolar lavage but less fluid is used to rinse larger airways
Bronchial mucosal biopsies - A small wire is inserted through the bronchoscope next to the bronchial lining Forceps at the end of the wire pinch off a small piece of tissue for withdrawal and examination
The patients heart rhythm and rate and oxygen levels are monitored during the procedure When the procedures are finished the patient is monitored in the ICU until the numbing effect of the anesthetic has worn off and then moves to a regular hospital bed for overnight
Patients whose test results show an isolated infection or isolated Wegeners lung tissue involvement and who are being treated or are eligible for treatment under another NIH protocol will be followed by X-ray for improvement of their infection or other lung involvement with treatment Patients whose infection or lung tissue involvement improves may be asked to undergo a second bronchoscopy as described above but for research purposes only
Patients between 18 and 75 years of age with Wegeners granulomatosis who require bronchoscopy to evaluate the cause of their lung problem may be eligible for this study
Participants will undergo a bronchoscopy in the hospital intensive care unit ICU For this procedure the mouth and throat are numbed with lidocaine jelly and spray If needed a sedative is given for comfort A small plastic tube intravenous catheter is placed in a vein to give medications A pencil-thin tube is then placed through the nose or mouth into the lung airways to examine the airways carefully
At the time of the bronchoscopy patients in this study will undergo the following additional procedures
Bronchoalveolar lavage - Saline salt water is injected through the bronchoscope into the air passage acting as a rinse A sample of the fluid is then withdrawn and examined for infection inflammatory cells and inflammatory chemicals This may be done as part of the standard medical care procedure
Bronchial lavage - This procedure is similar to bronchoalveolar lavage but less fluid is used to rinse larger airways
Bronchial mucosal biopsies - A small wire is inserted through the bronchoscope next to the bronchial lining Forceps at the end of the wire pinch off a small piece of tissue for withdrawal and examination
The patients heart rhythm and rate and oxygen levels are monitored during the procedure When the procedures are finished the patient is monitored in the ICU until the numbing effect of the anesthetic has worn off and then moves to a regular hospital bed for overnight
Patients whose test results show an isolated infection or isolated Wegeners lung tissue involvement and who are being treated or are eligible for treatment under another NIH protocol will be followed by X-ray for improvement of their infection or other lung involvement with treatment Patients whose infection or lung tissue involvement improves may be asked to undergo a second bronchoscopy as described above but for research purposes only
Detailed Description:
Wegeners granulomatosis is a systemic vasculitis in which parenchymal andor endobronchial inflammation frequently occur The purpose of this investigation is to analyze bronchial and bronchoalveolar lavage fluid in patients with Wegeners granulomatosis for the presence of immunoregulatory mediators and pro-inflammatory cytokines We will also be examining mucosal biopsies in these patients to define the histologic changes the phenotype of infiltrating leukocytes and the pattern of adhesion molecule expression that may be present Such studies could lead to an improved understanding of the pathophysiology of this disease and of its pulmonary manifestations and provide potential directions for future therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96-I-0065 | None | None | None |