Trial Outcomes & Findings for Topical Steroid Treatment for Eosinophilic Esophagitis (NCT NCT00275561)

Results Overview

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)?"

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

2 weeks

Results posted on

2012-05-08

Participant Flow

Adult patients with a new diagnosis of eosinophilic esophagitis were recruited at the Mayo Clinic Rochester between 10/2005 and 12/2009.

Participant milestones

Participant milestones
Measure	Fluticasone Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks	Placebo Placebo inhaler swallowed bid for 6 weeks
Overall Study STARTED	21	21
Overall Study COMPLETED	19	15
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluticasone Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks	Placebo Placebo inhaler swallowed bid for 6 weeks
Overall Study Withdrawal by Subject	0	1
Overall Study Travel	1	1
Overall Study Scheduling	1	2
Overall Study Family Issues	0	2

Baseline Characteristics

Topical Steroid Treatment for Eosinophilic Esophagitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluticasone n=21 Participants Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks	Placebo n=21 Participants Placebo inhaler swallowed bid for 6 weeks	Total n=42 Participants Total of all reporting groups
Age Continuous	37.5 years n=93 Participants	35 years n=4 Participants	37.5 years n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	16 Participants n=4 Participants	34 Participants n=27 Participants
Region of Enrollment United States	21 participants n=93 Participants	21 participants n=4 Participants	42 participants n=27 Participants
Food Impaction > 5 minutes Participants with Food Impaction	16 participants n=93 Participants	17 participants n=4 Participants	33 participants n=27 Participants
Food Impaction > 5 minutes Participants without Food Impaction	5 participants n=93 Participants	4 participants n=4 Participants	9 participants n=27 Participants
Mean Esophageal Eosinophil Count	40 eosinophils/high powered field n=93 Participants	40 eosinophils/high powered field n=4 Participants	40 eosinophils/high powered field n=27 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Analysis was run per protocol.

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)?"

Outcome measures

Outcome measures
Measure	Fluticasone n=19 Participants Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks	Placebo n=15 Participants Placebo inhaler swallowed bid for 6 weeks
Number of Participants With Complete Response to Dysphagia	9 participants	6 participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Analysis was run per protocol.

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.

Outcome measures

Outcome measures
Measure	Fluticasone n=19 Participants Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks	Placebo n=15 Participants Placebo inhaler swallowed bid for 6 weeks
Number of Participants With Partial or Complete Response to Dysphagia	12 participants	7 participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Analysis was run per protocol.

A complete histologic response was defined as \>90% decrease in mean eosinophil count/high powered field

Outcome measures

Outcome measures
Measure	Fluticasone n=19 Participants Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks	Placebo n=15 Participants Placebo inhaler swallowed bid for 6 weeks
Number of Participants With Complete Histologic Response	13 participants	0 participants

Adverse Events

Fluticasone

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fluticasone n=19 participants at risk Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks	Placebo n=15 participants at risk Placebo inhaler swallowed bid for 6 weeks
Gastrointestinal disorders Sore throat	10.5% 2/19 • Number of events 2 • 8 weeks 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.	20.0% 3/15 • Number of events 3 • 8 weeks 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.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/19 • 8 weeks 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.	20.0% 3/15 • Number of events 3 • 8 weeks 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.
Gastrointestinal disorders Esophageal candidiasis	26.3% 5/19 • Number of events 5 • 8 weeks 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.	0.00% 0/15 • 8 weeks 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.

Additional Information

Jeffrey A. Alexander, MD, Assistant Professor of Medicine

Mayo Clinic

Phone: 507-538-2403

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place