Completed

Analysis of Bronchial and Bronchoalveolar Lavage Fluid and Bronchial Mucosal Biopsies in Patients With Wegener's Granulomatosis

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What is being collected

Data Collection

Who is being recruted

Autoimmune Diseases+14

+ Cardiovascular Diseases

+ Immune System Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: April 1996
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1996

Actual date on which the first participant was enrolled.

Wegener's granulomatosis is a systemic vasculitis in which parenchymal and/or endobronchial inflammation frequently occur. The purpose of this investigation is to analyze bronchial and bronchoalveolar lavage fluid in patients with Wegener's 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.

NCT00001541
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesCardiovascular DiseasesImmune System DiseasesLung DiseasesPathologic ProcessesRespiratory Tract DiseasesSkin DiseasesPathological Conditions, Signs and SymptomsVascular DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularLung Diseases, InterstitialSystemic VasculitisAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisInflammationVasculitisGranulomatosis with Polyangiitis

Criteria

INCLUSION CRITERIA: Diagnosis of Wegener's granulomatosis based on clinical and histological characteristics. Age between 18-75 years. Bronchoscopy is required as part of their standard medical care. FEV1 is greater than 55 percent of FVC. O2 saturation is greater than 90 percent. EXCLUSION CRITERIA: FEV1 is less than 55% of FVC. O2 saturation is less than 90%. Abnormal PT, PTT, or platelet count less than 50. History of adverse reaction to lidocaine or other local anesthetics. Pregnancy.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, United StatesOpen National Institute of Allergy and Infectious Diseases (NIAID) in Google Maps
CompletedOne Study Center