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A Study of Flovent in Patients With Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT00426283
Recruitment Status : Completed
First Posted : January 24, 2007
Results First Posted : February 3, 2014
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Marc Rothenberg, MD, Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Eosinophilic Esophagitis
Interventions Drug: Flovent
Other: Placebo
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flovent 1760 mcg Placebo
Hide Arm/Group Description

Drug

Flovent : 1760 mcg daily

Placebo twice daily
Period Title: Overall Study
Started 28 14
Completed 23 13
Not Completed 5 1
Arm/Group Title Flovent 1760 mcg Placebo Total
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Drug

Flovent : 880 mcg twice daily

Placebo twice daily Total of all reporting groups
Overall Number of Baseline Participants 28 14 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 14 participants 42 participants
<=18 years
26
  92.9%
12
  85.7%
38
  90.5%
Between 18 and 65 years
2
   7.1%
2
  14.3%
4
   9.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 14 participants 42 participants
12.15  (6.42) 13.54  (7.11) 12.6  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 14 participants 42 participants
Female
6
  21.4%
1
   7.1%
7
  16.7%
Male
22
  78.6%
13
  92.9%
35
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 14 participants 42 participants
28 14 42
1.Primary Outcome
Title Percentage of Participants Who Attained Remission.
Hide Description Remission is considered achieved when the highest eosinophil count per high power field (hpf) in all esophageal biopsies is </= 1 eosinophil/hpf after 3 months of therapy.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flovent 1760 mcg Placebo
Hide Arm/Group Description:

Drug

Flovent : 880 mcg twice daily

Placebo twice daily
Overall Number of Participants Analyzed 23 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65.2
(44.9 to 81.2)
0
(0 to 22.8)
2.Secondary Outcome
Title Percent of Participants With Decreased Cortisol Levels After 3 Months
Hide Description Blood and saliva cortisol was measured and compared to reference range at 3 months. Participants with measures below the reference range were considered "decreased".
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flovent 1760 mcg Placebo
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Fluticasone propionate 880 mcg twice daily for 3 months

Flovent: 1760 mcg daily

Placebo twice daily
Overall Number of Participants Analyzed 23 13
Measure Type: Number
Unit of Measure: percentage of participants
17.4 0
3.Secondary Outcome
Title Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent
Hide Description Strength of the association (odds ratio) of age, body mass index (BMI) z-score , and allergic status with response to Flovent. Allergic status is defined as a history of allergic disease (allergic rhinitis, hay fever, atopic dermatitis, eczema, food anaphylaxis, asthma, or positive skin prick tests). Response is defined as <= 1 eosinophil/high power field in esophageal biopsies.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is restricted only to those that were given Flovent for the purpose of determining whether these specific variables are associated with response to drug
Arm/Group Title Flovent 1760 mcg
Hide Arm/Group Description:

Drug

Flovent : 1760 mcg daily

Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Odds Ratio
Odds Ratio for Age
0.907
(0.779 to 1.055)
Odds Ratio for BMI Z-Score
0.541
(0.205 to 1.433)
Odds Ratio for Allergic Status
0.572
(0.049 to 6.607)
4.Secondary Outcome
Title EoE Score After 3 Months
Hide Description The gene expression profile is associated with an EoE score algorithm reflecting disease status and severity in a quantifiable number - called the EoE score, based on a core set of 77 diagnostic genes. The EoE score was calculated for Flovent responders and placebo. Higher scores indicate normalization of genes associated with inflammation and fibrosis (disease severity). Therefore higher scores mean a better outcome. The minimum score is zero. There is no maximum score.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population includes only responders to Flovent and all participants finishing the study on Placebo.
Arm/Group Title Flovent 1760 mcg Responders Placebo
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Drug

Flovent : 1760 mcg daily

Placebo twice daily
Overall Number of Participants Analyzed 15 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
382  (47) 152  (119)
5.Secondary Outcome
Title Association of Compliance With Therapy and Response to Flovent
Hide Description Odds ratio was determined to show the strength of the association between compliance with the drug therapy and response to the drug therapy
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is restricted only to those that were given Flovent for the purpose of determining whether compliance with therapy was associated with response to drug
Arm/Group Title Flovent 1760 mcg
Hide Arm/Group Description:

Drug

Flovent : 1760 mcg daily

Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Odds Ratio
1.037
(0.988 to 1.089)
6.Secondary Outcome
Title Percent of Participants With Abdominal Pain After Therapy
Hide Description Percent of participants responding that they experienced abdominal pain (i.e. they did not respond "never") after therapy. Responses were dichotomized into "Never" and "sometimes".
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flovent 1760 mcg Placebo
Hide Arm/Group Description:

Drug

Flovent : 1760 mcg daily

Placebo
Overall Number of Participants Analyzed 23 12
Measure Type: Number
Unit of Measure: percentage of participants
63 50
Time Frame From consent to cessation of treatment which was approximately 4 months
Adverse Event Reporting Description Adverse events were reported according to the MedDRA System Organ Class
 
Arm/Group Title Flovent 1760 mcg Placebo
Hide Arm/Group Description

Drug

Flovent : 1760 mcg daily

Placebo : daily
All-Cause Mortality
Flovent 1760 mcg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/14 (0.00%)    
Hide Serious Adverse Events
Flovent 1760 mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flovent 1760 mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/28 (67.86%)      9/14 (64.29%)    
Eye disorders     
General Disorders *  0/28 (0.00%)  0 2/14 (14.29%)  2
Gastrointestinal disorders     
General Disorders *  7/28 (25.00%)  10 2/14 (14.29%)  2
General disorders     
General Disorders *  1/28 (3.57%)  1 1/14 (7.14%)  1
Immune system disorders     
General Disorders *  2/28 (7.14%)  3 0/14 (0.00%)  0
Infections and infestations     
General Disorders *  3/28 (10.71%)  4 3/14 (21.43%)  3
Injury, poisoning and procedural complications     
General Disorders *  1/28 (3.57%)  1 0/14 (0.00%)  0
Investigations     
General Disorders *  5/28 (17.86%)  5 1/14 (7.14%)  4
Nervous system disorders     
General Disorders *  4/28 (14.29%)  5 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
General Disorders *  3/28 (10.71%)  6 3/14 (21.43%)  3
Skin and subcutaneous tissue disorders     
General Disorders *  0/28 (0.00%)  0 1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marc E Rothenberg
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513-636-7177
EMail: rothenberg@cchmc.org
Layout table for additonal information
Responsible Party: Marc Rothenberg, MD, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00426283    
Other Study ID Numbers: 06-10-07
First Submitted: January 22, 2007
First Posted: January 24, 2007
Results First Submitted: December 16, 2013
Results First Posted: February 3, 2014
Last Update Posted: October 19, 2020