Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Infections

Ear, Nose, and Throat Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Rare Diseases

Recurrence

Lung Diseases, Obstructive

Lung Diseases

Sarcoidosis

Granulomatosis with Polyangiitis

Rhinoscleroma

Communicable Diseases

Respiratory Tract Infections

Papillomavirus Infections

Papilloma

Systemic Vasculitis

Respiratory Tract Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Hypersensitivity

Hypersensitivity, Delayed

Lung Diseases, Interstitial

Vasculitis

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Vascular Diseases

Skin Diseases

Skin Diseases, Vascular

Autoimmune Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Klebsiella Infections

Enterobacteriaceae Infections

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Skin Diseases, Bacterial

Skin Diseases, Infectious

Nose Diseases

Otorhinolaryngologic Diseases

Recurrent Respiratory Papillomatosis

Granulomatosis With Polyangiitis

ANCA-associated Vasculitis

Klebsiella Infection

Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days

CryoSpray Ablation

Michael Machuzak, M.D.

The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB)

The proposed study is a single center pilot study consisting of up to 10 subjects with benign airway disease. Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first three to seven days after the initial treatment, to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy per week with CSA therapy for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. If disease exists bilaterally, only one side will be sprayed initially.

Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")

Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")

need for additional treatments within specified period

CSA Medical, Inc.

All subjects enrolled will received CSA cryospray.

CryoSpray Ablation (tm): The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system.

All Subjects Receiving CSA Cryospray

subjects will receive up to 4 -5 second cycles of cryospray ablation

Cryo Spray Ablation

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Ann Murphy Legg, Director of Clinical Research

study terminated by Sponsor-data not analyzed

Improvement in Luminal Patency Following Cryospray Treatment

Treatment Durability

subjects receiving up to 4 -5 second spray cycles

Overall Study

Necrosis

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Gastrointestinal Agents

All Drugs and Chemicals

Etanercept

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Immunosuppressive Agents

Immunologic Factors

John H. Stone, MD, MPH

This study will determine if the drug etanercept, also called Enbrel, is effective in producing and maintaining remission (reduction of disease symptoms) of Wegener's granulomatosis (WG). Etanercept blocks the action of tumor necrosis factor-alpha, a substance that may be involved in inflammatory conditions such as WG. Eight clinical centers around the United States will enroll 181 people who have WG. Patients will have an equal chance to receive either etanercept or placebo (inactive treatment). We will treat patients with standard medications for WG in addition to either etanercept or placebo. We will treat all patients with tapering doses of corticosteroids.

After the patients' disease is controlled (in remission), we will reduce the dosages of the standard medications to lower the risk of side effects associated with these drugs. During the study, we will collect and save blood and tissues samples from patients and use the samples to address other medical questions, such as the cause of WG and factors that lead to disease progression.

The Wegener's Granulomatosis Etanercept Trial (WGET) is a randomized, placebo-controlled clinical trial. A primary objective of the trial is to evaluate the safety and efficacy of etanercept (Enbrel; Immunex Corporation, Seattle, WA) for the induction and maintenance of disease remissions for people with Wegener's granulomatosis (WG) when used in conjunction with standard medications. A secondary objective is to develop a specimen bank of serum, plasma, whole blood, and tissue biopsy samples that may be used to address basic questions regarding the etiology, pathophysiology, and monitoring of WG.

The trial is a phase II/III randomized, double-masked, multicenter trial with a parallel treatment design. We will assign patients randomly to either etanercept or placebo in an assignment ratio of 1:1. In addition to either etanercept or placebo, we will treat all patients with standard drug regimens for WG according to the severity of their disease. We will treat those with limited WG with methotrexate and corticosteroids, and those with severe WG with cyclophosphamide and corticosteroids. After the patients' disease is controlled with therapy (i.e., the standard treatment regimen plus either etanercept or placebo), we will taper the standard medications according to regimens designed to ensure patient safety, diminish morbidity associated with the standard medications, and test the efficacy of etanercept in sustaining disease remissions.

The principal outcome measure in this trial is the number of patients in the two treatment arms who achieve sustained remissions measured by the Birmingham Vasculitis Activity Score for WG (BVAS). The sample size is 181 patients recruited at eight clinical centers in the United States. We will stratify randomization by clinic and disease severity (limited versus severe). Every patient enrolled will have a BVAS of at least three, insuring unequivocally active disease.

We will follow all randomized patients, regardless of whether or not they remain on their assigned treatments, until the common closing date of the trial, defined as 12 months after enrollment of the last patient. We will perform the primary analyses on an intention-to-treat basis.

Etanercept for Wegener's Granulomatosis

Wegener's Granulomatosis Etanercept Trial (WGET)

FDA Office of Orphan Products Development

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

John H. Stone, M.D., M.P.H.

Antineoplastic Agents

Dermatologic Agents

Reproductive Control Agents

Methotrexate

Prednisone

This study will examine the use of etanercept (also called Enbrel or TNFR:Fc) in patients with Wegener's granulomatosis, a type of vasculitis (blood vessel inflammation). Wegener's granulomatosis may affect many parts of the body, including the brain, nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart, and other sites. Generally, the greater the disease involvement, the more life-threatening it is. Standard treatment is a combination of prednisone and a cytotoxic agent-usually cyclophosphamide or methotrexate. However, many patients treated with this regimen have a disease relapse, and others cannot take these drugs because of severe side effects. This study will evaluate etanercept's safety and effectiveness, and particularly its value in reducing the need for prednisone and preventing disease relapse.

The Food and Drug Administration has approved etanercept for treating rheumatoid arthritis, another inflammatory disease. The drug works by blocking the activity of TNF-a protein made by white blood cells that is involved in the inflammatory process. Since prednisone also affects inflammatory proteins and lowers TNF production, the use of etanercept may reduce the need for prednisone in patients with Wegener's granulomatosis, and thus the risk of its side effects.

Patients between 10 and 70 years of age with Wegener's granulomatosis who have never taken prednisone, methotrexate or cyclophosphamide, or have taken these drugs for less than 3 weeks may be eligible for this study.

Participants will have a medical history review and physical examination, including laboratory studies. If medically indicated, X-rays, consultations and biopsies (surgical removal of a small tissue sample) of affected organs will also be done. All patients will begin treatment with prednisone, methotrexate and etanercept. Those who improve on this regimen will stop prednisone gradually over 3 months. Those who achieve disease remission at the end of another 3 months will be randomly assigned to either continue taking etanercept and methotrexate for another 12 months or to stop etanercept and continue only methotrexate for the next 12 months (after which methotrexate will gradually be stopped). Patients who are not in remission by the 6-month point will continue taking etanercept until they go into remission, when they will be assigned to stop or not stop etanercept, as described above. Patients who do not achieve remission within 12 months of beginning treatment will be taken off the study. Patients who have a disease relapse while on the study will likely be switched to treatment with prednisone and either methotrexate or cyclophosphamide. Patients randomized to stop etanercept and who have a relapse within a year of stopping the drug may be offered re-treatment on this protocol, but with continuing etanercept for a full year after remission.

Patients will be evaluated in the outpatient clinic every 2 to 4 weeks for the first 4 months and every 1 to 3 months after that. Patients whose disease is in remission and who stop all medications will be followed every 3 to 6 months for 2 years. Follow-up evaluations include a physical examination, blood draws and, if medically indicated, X-rays. The total study duration is 60 to 70 months.

The purpose of the study is to assess the safety, pharmacokinetics, and immunologic effects of a recombinant fusion protein that consists of the soluble tumor necrosis factor receptor linked to the Fc portion of human IgG1 (TNFR:Fc) in patients with Wegener's granulomatosis. A secondary objective is to determine if TNFR:Fc demonstrates anti-inflammatory activity in the treatment of Wegener's granulomatosis. Specifically, we will seek to examine whether TNFR:Fc is able to reduce the need for glucocorticoid treatment and lower relapse rates. Patients will be eligible to participate in this protocol when there is evidence that the disease is active but is not immediately life-threatening. In this study, patients will receive TNFR:Fc (25mg subcutaneously twice weekly) together with methotrexate and prednisone. In all patients the prednisone will be tapered over a 3 month schedule. At the end of 6 months, patients in remission will be randomized to either continue TNFR:Fc for another 12 months or stop. All patients will continue methotrexate for 1 year after they enter remission after which time it will be tapered and discontinued.

Etanercept to Treat Wegener's Granulomatosis

Phase I/II Trial of TNFR:Fc (Etanercept) in Patients With Wegener's Granulomatosis

National Institute of Allergy and Infectious Diseases (NIAID)

Diseases and Abnormalities at or Before Birth

Syndrome

Carcinoma

Mycobacterium Infections

Carcinoma, Bronchogenic

Granulomatous Disease, Chronic

Job Syndrome

Gram-Positive Bacterial Infections

Phagocyte Bactericidal Dysfunction

Leukocyte Disorders

Hematologic Diseases

Genetic Diseases, X-Linked

Genetic Diseases, Inborn

Immunologic Deficiency Syndromes

Chronic Disease

Primary Immunodeficiency Diseases

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Chronic Graft Versus Host Disease

Chronic Granulomatous Disease

Hyper IgE Syndrome

Autosomal Dominant Hyper IgE Syndrome

virtual bronchoscopy

This study will evaluate a new technique for examining the air passages of the lungs called "virtual bronchoscopy." It involves using computed tomography (CT) images of the chest to generate a 3-dimensional model of the walls of the trachea and bronchi (airway passages). This non-invasive method lets doctors see small masses and areas of narrowing in the passages without having to do surgery or pass a tube through them.

Patients with diseases of the air passages who are enrolled in an NIH clinical trial may participate in this study, which requires having a CT scan. The patient lies on a table that slowly slides into a hole in a donut-shaped X-ray machine (the scanner). Patients may have to hold their breath several times during the procedure. Some patients may be given an injection of a contrast agent through a catheter (thin tube) placed in an arm vein to improve visibility of abnormalities. Patients may also be asked to breathe oxygen through nasal prongs to allow them to hold their breath longer. The procedure usually takes 15 to 20 minutes.

This project is a test of the efficacy of a new diagnostic method for imaging the airways known as virtual bronchoscopy. Virtual bronchoscopy is performed by acquiring thin section computed tomography (CT) images of the chest. These images are used to generate a three dimensional model of the tracheal and bronchial walls on a graphics workstation in 3-D. The model can be manipulated to allow the viewer to "fly through" the tracheobronchial tree providing views similar to those obtained during bronchoscopy. The technique produces a display of the human bronchial system in a readily understood format. Moreover, it allows investigation of post-stenotic portions of the bronchial tree that are beyond the reach of fiberoptic bronchoscopy. Further, virtual bronchoscopy may be used to guide interventional procedures. The patients that will be studied in this protocol will be those having inflammatory, infectious, or neoplastic pulmonary processes who would have had a chest CT for clinical reasons. These patients will be recruited from current NIH protocols. The study design consists of scanning of the thorax using thin section helical CT, followed by three dimensional surface rendering of the airways and transfer of the digital data to videotape. In one of four parts of the protocol, the virtual bronchoscopy will be compared with results from fiberoptic bronchoscopy in a blinded study. In a second part of the protocol, the virtual bronchoscopy will be used to perform a descriptive analysis of cavitary lung lesions. In the third part, the utility of virtual bronchoscopy in diagnosis of neoplastic lesions of the chest will be studied. In the fourth part, certain technical problems in the virtual bronchoscopy procedure will be investigated. The patients will only have fiberoptic bronchoscopy for clinically indicated purposes. We anticipate that virtual bronchoscopy will be diagnostically efficacious for disorders which produce a morphologic alteration in bronchial anatomy.

Diagnostic Effectiveness of Virtual Bronchoscopy

Diagnostic Efficacy of Virtual Bronchoscopy

National Institutes of Health Clinical Center (CC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")	NCT00747461	Lung Diseases, ... Sarcoidosis Wegener's Granu... Rhinoscleroma Recurrent Respi...	CryoSpray Ablat...	18 Years -	CSA Medical, Inc.
Etanercept for Wegener's Granulomatosis	NCT00005007	Wegener's Granu...	Etanercept	11 Years -	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Etanercept to Treat Wegener's Granulomatosis	NCT00001901	Vasculitis Wegener's Granu...	Etanercept	-	National Institutes of Health Clinical Center (CC)
Diagnostic Effectiveness of Virtual Bronchoscopy	NCT00001515	Bronchogenic Ca... Chronic Granulo... Job's Syndrome Mycobacterium I... Wegener's Granu...	virtual broncho...	-	National Institutes of Health Clinical Center (CC)
Diagnostic Effectiveness of Virtual Bronchoscopy	NCT00001515	Bronchogenic Ca... Chronic Granulo... Job's Syndrome Mycobacterium I... Wegener's Granu...	virtual broncho...	-	National Institutes of Health Clinical Center (CC)
Etanercept to Treat Wegener's Granulomatosis	NCT00001901	Vasculitis Wegener's Granu...	Etanercept	-	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for wegener's granulomatosis