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Topical Steroid Treatment for Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT00275561
Recruitment Status : Completed
First Posted : January 12, 2006
Results First Posted : December 8, 2011
Last Update Posted : May 8, 2012
Sponsor:
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Eosinophilic Esophagitis
Interventions Drug: Fluticasone
Drug: Placebo
Enrollment 42
Recruitment Details 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  
Arm/Group Title Fluticasone Placebo
Hide Arm/Group Description Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks Placebo inhaler swallowed bid for 6 weeks
Period Title: Overall Study
Started 21 21
Completed 19 15
Not Completed 2 6
Reason Not Completed
Withdrawal by Subject             0             1
Travel             1             1
Scheduling             1             2
Family Issues             0             2
Arm/Group Title Fluticasone Placebo Total
Hide Arm/Group Description Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks Placebo inhaler swallowed bid for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
37.5
(19 to 59)
35
(20 to 57)
37.5
(19 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
3
  14.3%
5
  23.8%
8
  19.0%
Male
18
  85.7%
16
  76.2%
34
  81.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 21 participants 42 participants
21 21 42
Food Impaction > 5 minutes   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Participants with Food Impaction 16 17 33
Participants without Food Impaction 5 4 9
[1]
Measure Description: Food stuck and unable to swallow liquids for >5 minutes
Mean Esophageal Eosinophil Count  
Mean (Full Range)
Unit of measure:  Eosinophils/high powered field
Number Analyzed 21 participants 21 participants 42 participants
40
(8 to 100)
40
(20 to 80)
40
(8 to 100)
1.Primary Outcome
Title Number of Participants With Complete Response to Dysphagia
Hide Description Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?"
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was run per protocol.
Arm/Group Title Fluticasone Placebo
Hide Arm/Group Description:
Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
Placebo inhaler swallowed bid for 6 weeks
Overall Number of Participants Analyzed 19 15
Measure Type: Number
Unit of Measure: participants
9 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluticasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Partial or Complete Response to Dysphagia
Hide Description Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?" A partial symptom response was defined as an answer of yes to the above question and a decrease in severity of at least 2 levels, or a decrease in frequency of at least 1 level.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was run per protocol.
Arm/Group Title Fluticasone Placebo
Hide Arm/Group Description:
Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
Placebo inhaler swallowed bid for 6 weeks
Overall Number of Participants Analyzed 19 15
Measure Type: Number
Unit of Measure: participants
12 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluticasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Complete Histologic Response
Hide Description A complete histologic response was defined as >90% decrease in mean eosinophil count/high powered field
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was run per protocol.
Arm/Group Title Fluticasone Placebo
Hide Arm/Group Description:
Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
Placebo inhaler swallowed bid for 6 weeks
Overall Number of Participants Analyzed 19 15
Measure Type: Number
Unit of Measure: participants
13 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluticasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description Safety was assessed with the side effect questionnaire at weeks 2 and 4 completed by a structured phone interview. The side effect questionnaire had questions on sore throat, hoarseness, white spots in the mouth, irritability, leg swelling, sleep disturbance, appetite change, acne, headache, diarrhea, nausea, and other new symptoms.
 
Arm/Group Title Fluticasone Placebo
Hide Arm/Group Description Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks Placebo inhaler swallowed bid for 6 weeks
All-Cause Mortality
Fluticasone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluticasone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluticasone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/19 (36.84%)      6/15 (40.00%)    
Gastrointestinal disorders     
Sore throat   2/19 (10.53%)  2 3/15 (20.00%)  3
Esophageal candidiasis   5/19 (26.32%)  5 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hoarseness   0/19 (0.00%)  0 3/15 (20.00%)  3
Indicates events were collected by systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jeffrey A. Alexander, MD, Assistant Professor of Medicine
Organization: Mayo Clinic
Phone: 507-538-2403
Responsible Party: Jeffrey A. Alexander, M.D, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275561     History of Changes
Other Study ID Numbers: 1488-05
First Submitted: January 10, 2006
First Posted: January 12, 2006
Results First Submitted: November 3, 2011
Results First Posted: December 8, 2011
Last Update Posted: May 8, 2012