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A Study of Flovent in Patients With Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00426283
Recruitment Status : Completed
First Posted : January 24, 2007
Results First Posted : February 3, 2014
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Marc Rothenberg, 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 1760 mcg
Hide Arm/Group Description

Drug

Flovent : 1760 mcg daily

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

Drug

Flovent : 1760 mcg daily

Placebo : 1760 mcg 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 The 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 1760 mcg
Hide Arm/Group Description:

Drug

Flovent : 1760 mcg daily

Placebo : 1760 mcg 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 To Investigate the Safety of 1760mcg FP in the Treatment of EE Using Measurement of Serial Salivary Cortisol Levels and Adverse Reaction Data.
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP.
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title To Investigate Subject Compliance and Response to FP.
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title To Investigate the Change in Subject Symptoms and Response to FP.
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flovent 1760 mcg Placebo 1760 mcg
Hide Arm/Group Description

Drug

Flovent : 1760 mcg daily

Placebo : 1760 mcg daily
All-Cause Mortality
Flovent 1760 mcg Placebo 1760 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Flovent 1760 mcg Placebo 1760 mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flovent 1760 mcg Placebo 1760 mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/28 (67.86%)      9/14 (64.29%)    
Eye disorders     
General Disorders  1  0/28 (0.00%)  0 2/14 (14.29%)  2
Gastrointestinal disorders     
General Disorders  1  7/28 (25.00%)  10 2/14 (14.29%)  2
General disorders     
General Disorders  1  1/28 (3.57%)  1 1/14 (7.14%)  1
Immune system disorders     
General Disorders  1  2/28 (7.14%)  3 0/14 (0.00%)  0
Infections and infestations     
General Disorders  1  3/28 (10.71%)  4 3/14 (21.43%)  3
Injury, poisoning and procedural complications     
General Disorders  1  1/28 (3.57%)  1 0/14 (0.00%)  0
Investigations     
General Disorders  1  5/28 (17.86%)  5 1/14 (7.14%)  4
Nervous system disorders     
General Disorders  1  4/28 (14.29%)  5 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
General Disorders  1  3/28 (10.71%)  6 3/14 (21.43%)  3
Skin and subcutaneous tissue disorders     
General Disorders  1  0/28 (0.00%)  0 1/14 (7.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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
Name/Title: Marc E Rothenberg
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513-636-7177
Responsible Party: Marc Rothenberg, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00426283     History of Changes
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: September 19, 2014