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Clinical trials
Clinical trial participation is an individual, and important, decision. Clinical trials are designed to test new medications in people. Clinical trials may involve a placebo group (inactive ‘medicine’) to see if the new medication offers an advantage over current standard treatment. Some trials are ‘open label’, in which all participants receive active medications or experimental treatment.
There are many advantages to participating in clinical trials. Participants in clinical trials at a minimum receive current standard care for their disease from medical teams experienced with the disease. Clinical trials also offer the opportunity to try a new medication long before it is approved by the Food and Drug Administration.
If you choose to participate in a clinical trial, you have the right to understand fully what is expected of you, what the trial will involve and the potential risks to your health. You also have the right to withdraw your consent to participate at any time. Learn more about clinical trials at . Trials That May be of Interest to Our Members
Eosinophilic Esophagitis Trials
Eosinophilic esophagitis (EE) is a disease that has become increasingly recognized in children and adults over the last decade.[1] It is characterized by an accumulation of eosinophils in the esophagus in association with symptoms that frequently mimic gastro-esophageal reflux disease (GERD).[2] Specifically, patients typically report symptoms that include difficulty feeding and failure to thrive in younger children, as well as vomiting, epigastric or chest pain, dysphagia, and food impaction.[2] The diagnosis must be made on the basis of an esophageal biopsy demonstrating the presence of significant numbers of eosinophils, clinical symptoms, and the absence of acid reflux or failure to respond to acid reduction therapy. [1]
Allergic responses have been strongly implicated in the etiology of EE. [1] The overexpression of the cytokine IL-5 by T helper type 2 cells is thought to play a major role in the pathogenesis of the disease. [1] Therapies currently utilized for EE include severely restricted diets, including an elemental formula diet typically administered by nasogastric or gastrostomy tube. [2] There are no approved pharmacologic therapies for EE, although corticosteroids are sometimes administered to patients.
[1] Furuta, G.., Liacouras, C., et al. Eosinophilic Esophagitis in Children and Adults: A Systemic Review and Consensus Recommendations for Diagnosis and Treatment. Gastroentergology 2007:133:1342-1363
[2] Blanchard, C., Wang, N., Rothenberg, M. Eosinophilic esophagitis: Pathogenesis, genetics, and therapy. J. Allergy Clin Immun. November 2006 (Vol. 118, Issue 5, Pages 1054-1059)
Reslizumab is a humanized mAb against IL-5. IL-5 plays a crucial role in the maturation, growth and chemotaxis of eosinophils, inflammatory cells implicated in a number of allergic diseases. The study (Res-05-0002) is a randomized, double-blind trial of reslizumab versus placebo in the treatment of pediatric patients between 5 and 18 years of age with poorly-controlled EE. Subjects will be randomized to one of three active dose groups or placebo, administered at monthly intervals for four months. The co-primary endpoints of the study are changes in clinical symptoms and esophageal eosinophil levels at the end of therapy. The clinical study is being conducted at multiple centers and will enroll approximately 172 patients. For more information on this clinical trial, please visit www.clinicaltrials.gov [Identifier: NCT00538434].
This study is a randomized clinical trial to evaluate 3 doses of mepolizumab in pediatric patients with eosinophilic esophagitis. The study will assess the safety and tolerability of mepolizumab, as well as its pharmacokinetics and capacity to decrease esophageal eosinophils. The patients eligible for enrollment in this study are those whose disease has not been adequately treated by other eosinophilic esophagitis therapies or those who are intolerant of these other treatments, including dietary therapies.
This study is open for recruitment. For further information: Clinical Trials.gov
EGID Trials
NIH Eosinophilic Gastroenteritis Research Study (PDF)
(Now enrolling for drug trial)
Randomized, double-blinded, drug trial assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).
Males and females ages 3-21 years, diagnosis of EE with characteristic endoscopic and histopathologic findings, referral to allergist prior to treatment.
History of poor tolerance to fluticasone propionate, patients on inhaled glucocorticoids, patients treated with systemic steroids within the last 3 months.
Clinical Research Coordinator IV, Division of Allergy and Immunology, Eosinophilic Team
Cincinnati Children's Hospital Medical Center
3333 Burnet Ave, Cincinnati, Oh 45229-3039
(513) 636-1317
HES Trials
Clinical Trials for Idiopathic HES
Intravenous Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES)
Hypereosinophilic syndrome (HES) is a rare disease
characterized by the triad of persistent peripheral
eosinophilia of 1500 eosinophils/mL, various end-organ injury (including skin, heart, lung,
nervous system and digestive system, etc), and exclusion of
known secondary causes of hypereosinophilia.
The major therapy for HES has been systemic corticosteroid
(‘steroids’) and other chemotherapeutic drugs (hydroxyurea,
interferon, and others) to lower eosinophilia and therefore to
slow down the progression of disease. Corticosteroids and
other therapies effectively reduce eosinophilia in some
patients, but many eventually either develop
significant side effects or diminished response to therapy.
Long-term therapeutic options therefore are limited.
Mepolizumab is a humanized monoclonal antibody that binds
specifically to human interleukin 5 (hIL-5) and inhibits its
activity. Previous human experience has shown it has
significant effect in reducing blood eosinophilia in atopic
and HES patients and can alleviate some HES clinical signs and
symptoms with a good safety profile. This study intends to
further evaluate the corticosteroid-sparing and clinical
benefit of mepolizumab in HES with a randomized
placebo-controlled trial.
CSS Trials
Investigators at the Asthma Research Center of Harvard's Brigham & Women's Hospital in Boston are looking for individuals with Churg-Strauss Syndrome to participate in a research study. Following confirmation of Churg-Strauss diagnosis by medical history review, the
study involves donation of blood and filling out of questionnaires. Up to $50 will be paid for time and expenses.
:
Call Dr. Michael Wechsler at 617-732-8202 or email Dr. Wechsler
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