Topical Steroid Treatment for Eosinophilic Esophagitis

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275561
First received: January 10, 2006
Last updated: May 1, 2012
Last verified: May 2012
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Eosinophilic Esophagitis
Interventions: Drug: Fluticasone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult patients with a new diagnosis of eosinophilic esophagitis were recruited at the Mayo Clinic Rochester between 10/2005 and 12/2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fluticasone Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
Placebo Placebo inhaler swallowed bid for 6 weeks

Participant Flow:   Overall Study
    Fluticasone     Placebo  
STARTED     21     21  
COMPLETED     19     15  
NOT COMPLETED     2     6  
Withdrawal by Subject                 0                 1  
Travel                 1                 1  
Scheduling                 1                 2  
Family Issues                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fluticasone Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
Placebo Placebo inhaler swallowed bid for 6 weeks
Total Total of all reporting groups

Baseline Measures
    Fluticasone     Placebo     Total  
Number of Participants  
[units: participants]
  21     21     42  
Age  
[units: years]
Mean ( Full Range )
  37.5  
  ( 19 to 59 )  
  35  
  ( 20 to 57 )  
  37.5  
  ( 19 to 59 )  
Gender  
[units: participants]
     
Female     3     5     8  
Male     18     16     34  
Region of Enrollment  
[units: participants]
     
United States     21     21     42  
Food Impaction > 5 minutes [1]
[units: participants]
     
Participants with Food Impaction     16     17     33  
Participants without Food Impaction     5     4     9  
Mean Esophageal Eosinophil Count  
[units: eosinophils/high¬†powered¬†field]
Mean ( Full Range )
  40  
  ( 8 to 100 )  
  40  
  ( 20 to 80 )  
  40  
  ( 8 to 100 )  
[1] Food stuck and unable to swallow liquids for >5 minutes



  Outcome Measures
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1.  Primary:   Number of Participants With Complete Response to Dysphagia   [ Time Frame: 2 weeks ]

2.  Secondary:   Number of Participants With Partial or Complete Response to Dysphagia   [ Time Frame: 2 weeks ]

3.  Secondary:   Number of Participants With Complete Histologic Response   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The relatively small sample size; unexpected high dropout rate in the placebo group; study commenced before the consensus definition of EoE advising exclusion of gastroesophageal reflux disease (GERD) was established.  


Results Point of Contact:  
Name/Title: Jeffrey A. Alexander, MD, Assistant Professor of Medicine
Organization: Mayo Clinic
phone: 507-538-2403
e-mail: alexander.jeffrey14@mayo.edu


Publications:

Responsible Party: Jeffrey A. Alexander, M.D, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275561     History of Changes
Other Study ID Numbers: 1488-05
Study First Received: January 10, 2006
Results First Received: November 3, 2011
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board