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Trial Outcomes & Findings for Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE) (NCT NCT00961233)

NCT ID: NCT00961233

Last Updated: 2012-11-06

Results Overview

Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

8 weeks

Results posted on

2012-11-06

Participant Flow

Participant milestones

Participant milestones
Measure
Inhaled/Swallowed Budesonide
inhaled/swallowed budesonide - nebulized budesonide 1mg twice daily that is swallowed.
Viscous/Swallowed Budesonide
viscous/swallowed budesonide - budesonide slurry (created with 5g sucralose) 1 mg twice daily that is swallowed
Overall Study
STARTED
13
12
Overall Study
COMPLETED
11
11
Overall Study
NOT COMPLETED
2
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Inhaled/Swallowed Budesonide
n=13 Participants
Viscous/Swallowed Budesonide
n=12 Participants
Total
n=25 Participants
Total of all reporting groups
Age Continuous
34.9 years
STANDARD_DEVIATION 7.3 • n=5 Participants
34.4 years
STANDARD_DEVIATION 7.5 • n=7 Participants
34.7 years
STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment

Outcome measures

Outcome measures
Measure
Inhaled/Swallowed Budesonide
n=11 Participants
Viscous/Swallowed Budesonide
n=11 Participants
Tissue Eosinophil Counts
89 # of eosinophils per high-power field
Standard Deviation 94
11 # of eosinophils per high-power field
Standard Deviation 23

SECONDARY outcome

Timeframe: 8 weeks

Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.

Outcome measures

Outcome measures
Measure
Inhaled/Swallowed Budesonide
n=11 Participants
Viscous/Swallowed Budesonide
n=11 Participants
Adrenal Insufficiency
0 participants
0 participants

Adverse Events

Inhaled/Swallowed Budesonide

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Viscous/Swallowed Budesonide

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

Evan S. Dellon, MD MPH

University of North Carolina School of Medicine

Phone: 919-966-2511

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place