Trial Outcomes & Findings for A Study of Flovent in Patients With Eosinophilic Esophagitis (NCT NCT00426283)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

3 months

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Flovent 1760 mcg Drug Flovent : 1760 mcg daily	Placebo Placebo twice daily
Overall Study STARTED	28	14
Overall Study COMPLETED	23	13
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Flovent in Patients With Eosinophilic Esophagitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flovent 1760 mcg n=28 Participants Drug Flovent : 880 mcg twice daily	Placebo n=14 Participants Placebo twice daily	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	26 Participants n=5 Participants	12 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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	12.15 years STANDARD_DEVIATION 6.42 • n=5 Participants	13.54 years STANDARD_DEVIATION 7.11 • n=7 Participants	12.6 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	14 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Flovent 1760 mcg n=23 Participants Drug Flovent : 880 mcg twice daily	Placebo n=13 Participants Placebo twice daily
Percentage of Participants Who Attained Remission.	65.2 percentage of participants Interval 44.9 to 81.2	0 percentage of participants Interval 0.0 to 22.8

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Flovent 1760 mcg n=23 Participants Drug Flovent : 880 mcg twice daily	Placebo n=13 Participants Placebo twice daily
Percent of Participants With Decreased Cortisol Levels After 3 Months	17.4 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 3 months

Population: 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

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.

Outcome measures

Outcome measures
Measure	Flovent 1760 mcg n=23 Participants Drug Flovent : 880 mcg twice daily	Placebo Placebo twice daily
Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent Odds Ratio for Age	0.907 Odds Ratio Interval 0.779 to 1.055	—
Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent Odds Ratio for BMI Z-Score	0.541 Odds Ratio Interval 0.205 to 1.433	—
Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent Odds Ratio for Allergic Status	0.572 Odds Ratio Interval 0.049 to 6.607	—

SECONDARY outcome

Timeframe: 3 months

Population: Population includes only responders to Flovent and all participants finishing the study on Placebo.

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.

Outcome measures

Outcome measures
Measure	Flovent 1760 mcg n=15 Participants Drug Flovent : 880 mcg twice daily	Placebo n=13 Participants Placebo twice daily
EoE Score After 3 Months	382 score on a scale Standard Deviation 47	152 score on a scale Standard Deviation 119

SECONDARY outcome

Timeframe: 3 months

Population: 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 was determined to show the strength of the association between compliance with the drug therapy and response to the drug therapy

Outcome measures

Outcome measures
Measure	Flovent 1760 mcg n=23 Participants Drug Flovent : 880 mcg twice daily	Placebo Placebo twice daily
Association of Compliance With Therapy and Response to Flovent	1.037 Odds Ratio Interval 0.988 to 1.089	—

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Flovent 1760 mcg n=23 Participants Drug Flovent : 880 mcg twice daily	Placebo n=12 Participants Placebo twice daily
Percent of Participants With Abdominal Pain After Therapy	63 percentage of participants	50 percentage of participants

Adverse Events

Flovent 1760 mcg

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Flovent 1760 mcg n=28 participants at risk Drug Flovent : 1760 mcg daily	Placebo n=14 participants at risk Placebo : daily
General disorders General Disorders	3.6% 1/28 • Number of events 1 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	7.1% 1/14 • Number of events 1 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class
Eye disorders General Disorders	0.00% 0/28 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	14.3% 2/14 • Number of events 2 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class
Gastrointestinal disorders General Disorders	25.0% 7/28 • Number of events 10 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	14.3% 2/14 • Number of events 2 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class
Immune system disorders General Disorders	7.1% 2/28 • Number of events 3 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	0.00% 0/14 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class
Infections and infestations General Disorders	10.7% 3/28 • Number of events 4 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	21.4% 3/14 • Number of events 3 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class
Injury, poisoning and procedural complications General Disorders	3.6% 1/28 • Number of events 1 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	0.00% 0/14 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class
Investigations General Disorders	17.9% 5/28 • Number of events 5 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	7.1% 1/14 • Number of events 4 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class
Nervous system disorders General Disorders	14.3% 4/28 • Number of events 5 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	0.00% 0/14 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class
Respiratory, thoracic and mediastinal disorders General Disorders	10.7% 3/28 • Number of events 6 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	21.4% 3/14 • Number of events 3 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class
Skin and subcutaneous tissue disorders General Disorders	0.00% 0/28 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class	7.1% 1/14 • Number of events 1 • From consent to cessation of treatment which was approximately 4 months Adverse events were reported according to the MedDRA System Organ Class

Additional Information

Marc E Rothenberg

Cincinnati Children's Hospital Medical Center

Phone: 513-636-7177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place