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Eosinophilia clinical trials

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NCT ID: NCT02484248 Active, not recruiting - Clinical trials for Functional Dyspepsia

Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia

Ketotifen
Start date: August 2015
Phase: Phase 3
Study type: Interventional

Acid reduction remains the most common treatment prescribed empirically by pediatric gastroenterologists for children with functional dyspepsia (FD). When acid reduction therapy fails to provide patients with a therapeutic effect, ketotifen and cromolyn, mast cell stabilizers, represent an attractive potential therapy given data implicating mast cells in the generation of dyspeptic symptoms. Although there have been no adult or pediatric studies on the use of mast cell stabilizers in patients with FD, benefit has been demonstrated in adults with IBS and children with eosinophilic gastroenteritis. Additionally, previous studies show mucosal eosinophilia is highly correlated with functional dyspepsia. Our usual current treatment pathway for functional dyspepsia in association with duodenal mucosal eosinophilia is as follows: acid-reducing medication/montelukast → addition of H1 antagonist → addition of budesonide → addition of oral cromolyn. If ketotifen is effective, it offers the advantage of being able to replace both the H1 antagonist and the oral cromolyn at a substantially reduced cost (approximately 10% of the cost of cromolyn alone). This study aims to introduce ketotifen earlier in the treatment pathway to examine its efficacy on children with functional dyspepsia in association with duodenal eosinophilia.

NCT ID: NCT02360696 Completed - Dyspepsia Clinical Trials

Functional Dyspepsia (FD) - Clinical Response to Montelukast in Children

Start date: August 2014
Phase:
Study type: Observational

Duodenal eosinophilia has been associated with dyspepsia in adults and the investigators have previously described the finding of duodenal mucosal eosinophilia in 71-79% of children undergoing diagnostic endoscopy. Previous studies in children have shown positive response to montelukast with approximately 50% finding complete relief and 20-30 percent showing no response. There are a number of factors that have the potential to contribute to the observed variability in response to montelukast. These include variability in: 1. systemic drug exposure (drug absorption, biotransformation and/or elimination) 2. regulation of leukotriene biosynthesis 3. cysteinyl leukotriene receptors and downstream mediators 4. patient disease phenotype (e.g. Functional Gastrointestinal Disorder (FGID) disease classification, psychologic profile) In this study, the investigators propose to utilize biopsy specimens stratified by drug response to identify candidate gene expression modules that will be validated in a prospective study design. The overall goal of this program is to develop a signature of montelukast response that can be applied not only to eosinophilic gastroenteritis, but more generally to other diseases, such as asthma, where the drug is widely used with variable success.

NCT ID: NCT02217332 Completed - Clinical trials for Chronic Sinusitis With Nasal Polyps and Eosinophilia

Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia

CS201
Start date: August 2014
Phase: Phase 2
Study type: Interventional

Phase 2, open-label, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal polyps and eosinophilia.

NCT ID: NCT01987076 Recruiting - Clinical trials for Drug Rash With Eosinophilia and Systemic Symptoms

Comparison Between Corticosteroid and Topical Steroids in the DRESS

DRESSCODE
Start date: October 2013
Phase: N/A
Study type: Interventional

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare and severe multiorgan adverse drug reaction occurring within 2 to 6-8 weeks after a new drug intake. DRESS syndrome is defined by the combination of clinical manifestations, cutaneous, visceral and biological disturbances. Its prognosis is directly linked to severity of visceral involvement, with a mortality evaluated above 10%. Considering curative treatment, there is no consensus. Until now, no controlled trial has been performed. Systemic steroids are mainly used in first intention, in particular for management of visceral involvements, whatever their severity. From clinical practice, topical steroids are often used and could be helpful in the therapeutic management of DRESS. We propose to evaluate systemic steroids versus very potent topical steroids in a multicentric randomized controlled trial including defined moderate DRESS, ie the non-inferiority of very potent topical steroids in terms of remission of visceral involvement at Day30 and the superiority of very potent topical steroids in terms of delay to remission of skin involvement.

NCT ID: NCT01814059 Terminated - Clinical trials for Eosinophilic Esophagitis

Sirolimus for Eosinophil-Associated Gastrointestinal Disorders

Start date: March 7, 2013
Phase: Phase 1
Study type: Interventional

Background: - Eosinophil-associated gastrointestinal disorders (EGID) are a group of related disorders that affect the esophagus, stomach, and bowel. There are two major types of EGID, eosinophilic esophagitis and eosinophilic gastroenteritis. They are caused by the body's immune system being activated by food allergens, which then damages the gut wall. People with EGID have large numbers of eosinophils (a type of white blood cell) in their gut. EGID can cause difficulty swallowing, abdominal pain, or nausea. - At present, there are no drugs specifically approved to treat EGID. Most adults who have EGID receive steroid therapy to manage the symptoms. However, long-term steroid use may cause other problems in the body. Researchers want to see if low-dose sirolimus can be used to treat EGID. Sirolimus is a drug used to prevent rejection of transplanted organs. It may be able to keep the body's immune cells from being activated by food allergens and decrease the eosinophils. Objectives: - To see if low dose sirolimus is safe and decreases blood or gut eosinophils in EGID. Eligibility: - Individuals between 18 to 65 years of age who have EGID. - Participants must also have an elevated blood eosinophil count and positive blood tests for IgE antibodies to foods. Design: - Participants who are on medicine for EGID or related symptoms must be on a stable dose for 1 month before screening and stay on that dose throughout the study. - Participants will be screened with a medical history and physical exam, and review their symptoms. They will provide blood and urine samples. They will also have heart and lung function tests. Some participants may have allergy skin tests. - At the first study visit, participants will have 2 days of inpatient tests. They will repeat the tests from the screening visit. They will also have a full analysis of the esophagus, stomach, and small intestine. On the second day, they will start to take sirolimus as a liquid with orange juice or water. - Participants will continue to take sirolimus at home. They will record their doses and any symptoms. They will also have a visit to provide blood samples about 2 weeks after the first study visit. - At the second study visit (about a month after the first visit), participants will repeat the tests from the screening visit. The sirolimus dose may be adjusted as needed. - Participants will take sirolimus for at least another 28 days. Depending on the dose of the drug and the blood test results, some participants may need to take it for up to 112 days. Those who take the drug for a longer period will have additional study visits with tests. - There will be another study visit when participants stop taking the drug. The last visit will be a final follow-up visit.

NCT ID: NCT01779154 Withdrawn - Clinical trials for Eosinophilic Esophagitis

Eosinophilic Gastrointestinal Disorders Patient Registry

Start date: January 2013
Phase: N/A
Study type: Observational [Patient Registry]

The Eosinophilic Gastrointestinal Disorders (EGIDS) Registry is a longitudinal study that does not involve medical interventions, but serves as a record of demographics, characteristics of disease and treatment, utilization patterns, quality improvement measures and clinical outcomes. The database is proposed so that epidemiologic research can be performed and current and accurate data can be obtained regarding practice patterns, age and gender distributions, efficacy of treatment, clinical outcomes and changes in quality of life.

NCT ID: NCT01576367 Completed - Clinical trials for Familial Cold Autoinflammatory Syndrome

Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

Start date: January 16, 2012
Phase: Phase 3
Study type: Interventional

This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS patients that completed the CACZ885D2307 study

NCT ID: NCT01545726 Completed - Asthma Clinical Trials

Safety and Efficacy of QAW039 in Sputum Eosinophilia and Persistent Asthma

Start date: February 2012
Phase: Phase 2
Study type: Interventional

This study will assess the safety and efficacy of QAW039 when added to current therapy in patients that have sputum eosinophilia and persistent asthma.

NCT ID: NCT01524536 Completed - Clinical trials for Hematologic Diseases

Steroid Treatment for Hypereosinophilic Syndrome

Start date: February 16, 2012
Phase: Phase 4
Study type: Interventional

Background: - Hypereosinophilic syndrome (HES) is a disorder in which the body has too many eosinophils (a type of white blood cell). Too many eosinophils in HES can cause damage to the heart, nerves, or skin. Certain drugs can help lower eosinophil counts to prevent tissue damage. Corticosteroids, such as prednisone, are used for initial therapy in this disorder. Although most people respond to prednisone, some people develop side effects from it, or do not respond very well to treatment. Better ways of determining the dose to give could help to decide on the best therapy for HES. Objectives: - To determine whether a single-dose of prednisone can be used to predict which people with hypereosinophilia respond to treatment. - To study lack of response to steroid treatment in people with HES. Eligibility: Inclusion criteria: - Individuals with hypereosinophilic syndrome with high eosinophil counts. - Individuals who are willing to have blood drawn before and after getting steroids. Exclusion criteria: - Individuals who are on more than 10mg of prednisone (or similar drug) - Individuals with hypereosinophilic syndrome who are on other medications that could interfere with the study - Women who are pregnant or breast-feeding - Individuals who have a known gene mutation associated with chronic eosinophilic leukemia - Children less than 18 years old who weigh less than 48kg or 106lb Design: - Participants will have a screening visit with a physical exam and medical history. Blood and urine samples will be collected. - Participants will have a single dose of the steroid prednisone by mouth in the morning. Blood samples will be collected 2, 4, 24 hours after this dose. - On the day after the steroid dose, participants will provide another blood sample in the morning. - Participants will start to take prednisone daily when they return home. Blood samples will be collected weekly at the participant s doctor s office. The dose of prednisone will be lowered depending on the weekly eosinophil count. We will try to get each person on the lowest dose of prednisone possible that will control the disorder. Participants who do not respond or have severe side effects will be taken off prednisone. Other treatments will be considered for people who do not respond to steroids. The goal is to evaluate the response to prednisone. Our research will try to figure out why some people do not respond to steroids. Most people will complete the study within 6 to 16 weeks, depending on their response to prednisone.

NCT ID: NCT01382563 Completed - Clinical trials for Eosinophilic Esophagitis

Registry for Eosinophilic Gastrointestinal Disorders (REGID)

EoE
Start date: November 2012
Phase:
Study type: Observational

Develop Registry tool