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A Study of Flovent in Patients With Eosinophilic Esophagitis
This study is currently recruiting participants.
Study NCT00426283   Information provided by Children's Hospital Medical Center, Cincinnati
First Received: January 22, 2007   Last Updated: August 26, 2009   History of Changes

January 22, 2007
August 26, 2009
January 2007
July 2011   (final data collection date for primary outcome measure)
To investigate the ability of 1760mcg fluticasone propionate (FP) swallowed from a metered-dose inhaler (MDI) to induce remission of eosinophilic esophagitis (EE) (highest count of eosinophils per HPF for all esophageal biopsies to < 1 cell per HPF. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
To investigate the ability of 1760mcg fluticasone propionate (FP) swallowed from a metered-dose inhaler (MDI) to induce remission of eosinophilic esophagitis (EE) (highest count of eosinophils per HPF for all esophageal biopsies to < 1 cell per HPF.
Complete list of historical versions of study NCT00426283 on ClinicalTrials.gov Archive Site
  • To investigate the safety of 1760mcg FP in the treatment of EE using measurement of serial salivary cortisol levels and adverse reaction data. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: Yes ]
  • To investigate the relationship between subject age, height, weight, allergic status and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
  • To investigate the relationship between gene expression, blood levels (CBC, serum IL-5, eotaxin-3 and IgE) eosinophil phenotype, (via flow cytometry and functional responses) and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
  • To investigate subject compliance and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
  • To investigate the change in subject symptoms and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
  • To investigate the safety of 1760mcg FP in the treatment of EE using measurement of serial salivary cortisol levels and adverse reaction data.
  • To investigate the relationship between subject age, height, weight, allergic status and response to FP.
  • To investigate the relationship between gene expression, blood levels (CBC, serum IL-5, eotaxin-3 and IgE) eosinophil phenotype, (via flow cytometry and functional responses) and response to FP.
  • To investigate subject compliance and response to FP.
  • To investigate the change in subject symptoms and response to FP.
 
A Study of Flovent in Patients With Eosinophilic Esophagitis
A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis

The purpose of this study is to test the effects (both good and bad) of swallowed fluticasone propionate (Flovent), in subjects with eosinophilic esophagitis (EE).

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Eosinophilic Esophagitis
  • Drug: Flovent
  • Other: Placebo
Experimental: Drug
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent for study by subject, or parent/guardian if subject is a minor. Assent will be obtained from all minors 11 years of age and older.
  • Histological findings on esophageal biopsy to include peak eosinophil density ≥24 per high power field (400x) in the proximal or distal esophagus validated by a pathologist at CCHMC.
  • Allergy evaluation including skin-prick testing with multiple food antigens to ensure elimination diet is not indicated.
  • Have undergone a minimum 3 months of elimination diet as indicated by skin-prick testing without detectable resolution by repeat endoscopy with biopsies demonstrating persistent EE OR subject/parental refusal to follow elimination diet. If the subject/parent refuses the elimination diet, they are eligible for this study.
  • Treatment with a proton-pump inhibitor for at least two months prior to endoscopy OR failure of histological improvement as defined by <1 eosinophil per HPF after 2 month trial of proton pump inhibitor documented by prior endoscopy. The PPI must be used prior to endoscopy to rule out the possibility of GERD.

Exclusion Criteria:

  • History of poor tolerance to FP, as defined as multiple episodes of oral candidiasis, hypothalamic-pituitary-adrenal axis suppression as evidenced by signs of Cushing syndrome, headaches, or increased respiratory infections during exposure to Flovent
  • Unable to cooperate with use of MDI
  • Pregnant females
  • Concurrent or recent (within 3 months) use of systemic corticosteroids.
  • Unable to swallow medicines (i.e., fed only by gastrostomy tube).
  • Comorbid eosinophilic disorders.
  • Previously treated with swallowed glucocorticoid for EE within 3 months of the screening visit.
Both
3 Years to 30 Years
No
Contact: Bridget K Buckmeier Butz, M.H.S.A 513-636-5540 bridget.buckmeier@cchmc.org
United States
 
NCT00426283
Marc E. Rothenberg, Cincinnati Children's Hospital
06-10-07
Children's Hospital Medical Center, Cincinnati
 
Principal Investigator: Marc E. Rothenberg, M.D., Ph.D. Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP