Trial · NCT00426283

A Study of Flovent in Patients With Eosinophilic Esophagitis

NCT00426283, Phase 2, Completed, Marc Rothenberg, MD; results first posted 2014-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Flovent in Patients With Eosinophilic Esophagitis. Trials, record NCT00426283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00426283

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Flovent in Patients With Eosinophilic Esophagitis
NCT number: NCT00426283
Status: Completed
Phases: Phase 2
Enrollment: 42 participants, actual
Lead sponsor: Marc Rothenberg, MD
Conditions: Eosinophilic Esophagitis
Interventions: Flovent, Placebo
First posted: 2007-01-24
Last updated: 2020-10-19
Results first posted: 2014-02-03

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Attained Remission.	3 months	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.
Secondary	Percent of Participants With Decreased Cortisol Levels After 3 Months	3 months	Blood and saliva cortisol was measured and compared to reference range at 3 months. Participants with measures below the reference range were considered "decreased".
Secondary	Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent	3 months	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.
Secondary	EoE Score After 3 Months	3 months	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.
Secondary	Association of Compliance With Therapy and Response to Flovent	3 months	Odds ratio was determined to show the strength of the association between compliance with the drug therapy and response to the drug therapy
Secondary	Percent of Participants With Abdominal Pain After Therapy	3 months	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".

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Attained Remission.	3 months		percentage of participants	NUMBER
SECONDARY	Percent of Participants With Decreased Cortisol Levels After 3 Months	3 months		percentage of participants	NUMBER
SECONDARY	Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent	3 months	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	Odds Ratio	NUMBER
SECONDARY	EoE Score After 3 Months	3 months	Population includes only responders to Flovent and all participants finishing the study on Placebo.	score on a scale	MEAN
SECONDARY	Association of Compliance With Therapy and Response to Flovent	3 months	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	Odds Ratio	NUMBER
SECONDARY	Percent of Participants With Abdominal Pain After Therapy	3 months		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Who Attained Remission.	Flovent 1760 mcg		65.2	95% Confidence Interval 44.9 to 81.2	percentage of participants
Percentage of Participants Who Attained Remission.	Placebo		0	95% Confidence Interval 0 to 22.8	percentage of participants
Percent of Participants With Decreased Cortisol Levels After 3 Months	Flovent 1760 mcg		17.4		percentage of participants
Percent of Participants With Decreased Cortisol Levels After 3 Months	Placebo		0		percentage of participants
Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent	Flovent 1760 mcg	Odds Ratio for Age	0.907	95% Confidence Interval 0.779 to 1.055	Odds Ratio
Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent	Flovent 1760 mcg	Odds Ratio for BMI Z-Score	0.541	95% Confidence Interval 0.205 to 1.433	Odds Ratio
Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent	Flovent 1760 mcg	Odds Ratio for Allergic Status	0.572	95% Confidence Interval 0.049 to 6.607	Odds Ratio
EoE Score After 3 Months	Flovent 1760 mcg Responders		382	Standard Deviation 47	score on a scale
EoE Score After 3 Months	Placebo		152	Standard Deviation 119	score on a scale
Association of Compliance With Therapy and Response to Flovent	Flovent 1760 mcg		1.037	95% Confidence Interval 0.988 to 1.089	Odds Ratio

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Flovent 1760 mcg	28
Overall Study	STARTED	Placebo	14
Overall Study	COMPLETED	Flovent 1760 mcg	23
Overall Study	COMPLETED	Placebo	13
Overall Study	NOT COMPLETED	Flovent 1760 mcg	5
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	General Disorders	General disorders	Flovent 1760 mcg	1	28	1
other	General Disorders	General disorders	Placebo	1	14	1
other	General Disorders	Eye disorders	Flovent 1760 mcg	0	28	0
other	General Disorders	Eye disorders	Placebo	2	14	2
other	General Disorders	Gastrointestinal disorders	Flovent 1760 mcg	7	28	10
other	General Disorders	Gastrointestinal disorders	Placebo	2	14	2
other	General Disorders	Immune system disorders	Flovent 1760 mcg	2	28	3
other	General Disorders	Immune system disorders	Placebo	0	14	0
other	General Disorders	Infections and infestations	Flovent 1760 mcg	3	28	4
other	General Disorders	Infections and infestations	Placebo	3	14	3

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Flovent 1760 mcg	0	28
Total, all-cause mortality	Placebo	0	14
Total, other adverse events	Flovent 1760 mcg	19	28
Total, other adverse events	Placebo	9	14
Total, serious adverse events	Flovent 1760 mcg	0	28
Total, serious adverse events	Placebo	0	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24768678	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Flovent 1760 mcg vs Placebo: deaths from any cause	Trial comparisons
Flovent 1760 mcg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00426283

GET https://conductscience.org/api/trials/v1/NCT00426283/registered

API reference For AI assistants