A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
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| ClinicalTrials.gov Identifier: NCT00266578 |
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Recruitment Status :
Completed
First Posted : December 19, 2005
Last Update Posted : April 11, 2013
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Sponsor:
Marc Rothenberg
Information provided by (Responsible Party):
Marc Rothenberg, Children's Hospital Medical Center, Cincinnati
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Brief Summary:
The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Eosinophilic Esophagitis | Drug: Fluticasone Propionate | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial |
| Study Start Date : | October 2002 |
| Actual Primary Completion Date : | November 2006 |
| Actual Study Completion Date : | October 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Eosinophilic Esophagitis
Intervention Details:
- Drug: Fluticasone Propionate
Flovent vs. placebo daily for 3 months
Primary Outcome Measures :
- Histologic remission [ Time Frame: 5 years ]Histologic remission,defined by a peak eosinophil count of less than/equal to 1 eosinophil in all 400 fields in both the proximal and distal esophagus.
Secondary Outcome Measures :
- Furrowing, Epithelial hyperplasia, clinical symptoms [ Time Frame: 5 years ]Secondary outcome measures included presence of endoscopic furrowing, presence of epithelial hyperplasia, and presence of clinical symptoms.
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| Ages Eligible for Study: | 3 Years to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed informed consent for study by parent or guardian. Assent will be obtained from all minors 11 years of age and older.
- Age older than or equal to 3 years and younger than or equal to 30 years
- Endoscopic findings consistent with EE (edema, furrowing, exudates, rings)
- Histological findings to include proliferation of basal layer and peak eosinophil density ≥24 per high power field (400x). This degree of tissue eosinophilia has been shown to correlate well with poor-responsiveness to acid suppression therapy, suggesting it is a primary eosinophilic disease and not secondary to GERD[11].
- Allergy evaluation including skin-prick testing with multiple food antigens to insure elimination diet is not indicated.
- If allergic to specific foods, option to be on a minimum 3 months of elimination diet without detectable resolution by repeat endoscopy with biopsies demonstrating no improvement to disease.
- Patients enrolled at CCHMC will be under the direct care of Dr. Putnam or any of the other staff gastroenterologists at this institution who will supervise endoscopic procedures. Patients may also be enrolled at institutions other than CCHMC, but the diagnosis of EE must be validated by an expert pathologist in EE at CCHMC (Margaret Collins, MD).
- 20 additional patients without EE will be enrolled as unaffected controls for purposes of comparison with patients with EE. Enrollment pool will comprise patients undergoing routine upper endoscopy and having no identifiable pathology.
Exclusion Criteria:
- Patients with history of poor tolerance to FP, patients unable to cooperate with use of MDI, pregnant females, patients inhaling any corticosteroid for asthma, and patients with concurrent or recent (within 3 months) use of systemic steroids.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266578
Locations
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
Sponsors and Collaborators
Marc Rothenberg
Investigators
| Principal Investigator: | Marc E. Rothenberg, M.D., Ph.D. | Children's Hospital Medical Center, Cincinnati |
| Responsible Party: | Marc Rothenberg, MD, PhD, Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00266578 History of Changes |
| Other Study ID Numbers: |
02-9-9 FAAN |
| First Posted: | December 19, 2005 Key Record Dates |
| Last Update Posted: | April 11, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Marc Rothenberg, Children's Hospital Medical Center, Cincinnati:
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Eosinophilic Esophagitis |
Additional relevant MeSH terms:
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Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Fluticasone Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents |