Trial Outcomes & Findings for Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis (NCT NCT00895817)

Results Overview

Histologic resolution of esophageal eosinophilia. Response is defined as achieving \< 7 eosinophils/high power field in both the proximal and distal esophagus.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

8 weeks

Results posted on

2013-03-12

Participant Flow

Subjects with symptoms of esophageal dysfunction were recruited from the GI clinic of Walter Reed Army Medical Center. Recruitment dates were from 2008-2010.

Subjects with a confirmed diagnosis of EE based on symptoms and tissue biopsies were offered enrollment.All subject underwent 24-hour pH studies to stratify GERD positive and GERD negative. A computer generated list of random numbers was then used to separate patients into two equal treatment groups (esomeprazole and fluticasone proprionate).

Participant milestones

Participant milestones
Measure	Esomeprazole Esomeprazole : 40 mg once daily for 8 weeks	Swallowed Fluticasone Swallowed fluticasone : 440 µg twice daily for 8 weeks
Overall Study STARTED	21	21
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esomeprazole n=21 Participants Esomeprazole : 40 mg once daily for 8 weeks	Swallowed Fluticasone n=21 Participants Swallowed fluticasone : 440 µg twice daily for 8 weeks	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	38 years STANDARD_DEVIATION 10 • n=5 Participants	38 years STANDARD_DEVIATION 10 • n=7 Participants	38 years STANDARD_DEVIATION 19 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Sample size estimation was based on the assumptions:10% of the EE patients will respond to PPI compared to 55% of patients treated with steroids. Controlling the probability of a Type I error at alpha=0.05, a sample of 38 patients in the treatment groups (19 in each arm) will have 80% power to detect a difference in treatment response of 45%.

Histologic resolution of esophageal eosinophilia. Response is defined as achieving \< 7 eosinophils/high power field in both the proximal and distal esophagus.

Outcome measures

Outcome measures
Measure	Esomeprazole n=21 Participants Esomeprazole : 40 mg once daily for 8 weeks	Swallowed Fluticasone n=21 Participants Swallowed fluticasone : 440 µg twice daily for 8 weeks
Number of Participants Who Responded	7 participants	4 participants

SECONDARY outcome

Timeframe: 8 weeks

Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Following therapy, resolution of EE findings will be assessed.

Outcome measures

Outcome data not reported

Adverse Events

Esomeprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Swallowed Fluticasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Fouad J Moawad

Walter Reed Army Medical Center

Phone: (301) 295-4600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place