OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

Study Description

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Brief Summary:

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

Condition or disease	Intervention/treatment	Phase
Eosinophilic Esophagitis	Drug: Oral Budesonide Suspension (MB-9); Drug: Placebo	Phase 2

Detailed Description:

Eosinophilic Esophagitis (EoE) is an inflammatory disorder of the esophagus and is a recognized clinical entity. Symptoms include feeding problems, heartburn, regurgitation, vomiting, abdominal pain and food impaction. The symptoms of EoE may be similar to gastroesophageal reflux disease (GERD) but do not resolve with gastric acid suppression. EoE is defined histologically as the presence of > 15 intraepithelial eosinophils per high power fields on one or more esophageal biopsy specimens.

This Phase II study is comparing oral budesonide (OBS) to placebo to demonstrate that OBS induces a histologic response and a symptom response using a Dysphagia Symptom Questionnaire over a 16 week course of therapy.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	93 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension
Study Start Date :	July 2012
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	October 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Oral Budesonide Suspension; Taken once or twice daily for up to 40 weeks	Drug: Oral Budesonide Suspension (MB-9); OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period
Placebo Comparator: Matching Placebo; Taken once or twice daily for 20 weeks	Drug: Placebo

Outcome Measures

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Primary Outcome Measures :

1. Percent of Participants Who Were Histologic Responders [ Time Frame: Week 16 ]
   Histologic response was defined as a peak eosinophil count </= 6/high power field (light microscopy) (HPF) across all esophageal levels at the final treatment evaluation (Week 16). An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.
2. Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation [ Time Frame: Baseline, Week 16 ]
   Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.

Secondary Outcome Measures :

1. Change From Baseline in The DSQ Score Over Time [ Time Frame: Baseline, Weeks 8 and 12 ]
   Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.
2. Change From Baseline in The DSQ Score For The 50th Percentile of Participants at The Final Treatment Period Evaluation [ Time Frame: Baseline, Week 16 ]
   A cumulative distribution function curve was constructed to illustrate the cumulative proportion of participants (x-axis) vs. the change in the DSQ score from baseline to the final treatment evaluation (y-axis). The 50th percentile is participants with a DSQ score that is in the middle of the distribution of all scores. A negative change from baseline indicates that symptoms decreased.
3. Percent of Participants With a Peak Eosinophil Count </= 15/High Power Field (Light Microscopy) (HPF) And </= 1/HPF at The Final Treatment Period Evaluation [ Time Frame: Week 16 ]
   An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. The values reported are for participants with histologic response.
4. Percent of Participants With a >/= 30% And >/= 50% Reduction In The DSQ Score From Baseline to The Final Treatment Period Evaluation [ Time Frame: Baseline, Week 16 ]
   Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization.
5. Percent of Participants Who Were Overall Responders at The Final Treatment Period Evaluation [ Time Frame: Week 16 ]
   Overall response was defined as a reduction in the 2-week DSQ score of >/= 30% and >/= 50% from baseline to the final treatment period evaluation and a peak eosinophil count of </= 6/high power field (light microscopy) (HPF) across all available esophageal levels at the final treatment period evaluation. An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.
6. Change From Baseline in The Histopathologic Epithelial Features Combined Total Score at The Final Treatment Period Evaluation [ Time Frame: Baseline, Week 16 ]
   Each esophageal biopsy specimen was evaluated microscopically by an independent, central pathologist for signs of epithelial inflammation and lamina propria fibrosis. Histopathologic epithelial features of each available esophageal level biopsy consisting of basal layer hyperplasia, eosinophil peak, dilated intercellular spaces, eosinophil microabcesses, surface layering, surface alteration, and apoptotic epithelial cells were scored and summed. Histopathology data were collected in a blinded fashion. Histopathology epithelial features were scored for both grade and stage. Each feature had a possible score of 0-3 for grade as well as stage. Thus each of the 3 levels had a possible score of 21, and a possible total grade or stage score of 63 for a maximum combined score of 126. The grade and stage score of the lamina propria was not included because the biopsy material was not available. A negative change from baseline indicates that epithelial inflammation decreased.
7. Change From Baseline in The Total Endoscopy Score at The Final Treatment Period Evaluation [ Time Frame: Baseline, Week 16 ]
   The gross endoscopic appearance of the esophageal surface was evaluated by a blinded study center physician. Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 major categories, including exudates or plaques, fixed esophageal rings, edema, furrows, and strictures. The endoscopy score was the sum of the scores for the 5 major categories - grade 0-1 for strictures; grade 0-2 for exudates or plaques, edema, and furrows; and grade 0-3 for fixed esophageal rings for the proximal and distal locations. The maximum endoscopy score was 10 points for each location (proximal and distal), and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points). Baseline was defined as the endoscopy score at screening. A negative change from baseline indicates that appearance improved.
8. Change From Baseline in The Peak Eosinophil Count at Each Available Esophageal Level at The Final Treatment Period Evaluation [ Time Frame: Baseline, Week 16 ]
   An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. Baseline was defined as the score at screening. A negative change from baseline indicates that eosinophil count decreased.
9. Change From Baseline in The Physician's Global Assessment (PGA) of Disease Activity at The Final Treatment Period Evaluation [ Time Frame: Baseline, Week 16 ]
   The physician Investigator (or qualified physician's assistant or nurse practitioner) completed the PGA to provide the global assessment of eosinophilic esophagitis (EoE) disease activity using a 0 to 100 mm visual analog scale (VAS) scale. The VAS is a 100 mm horizontal line on which the right extreme (100) is labeled "worst possible disease activity" and the left extreme (0) is labeled "no disease activity". The PGA raters were instructed to consider the line for the VAS a continuum with their own medical opinion or judgment of extremes on either end and to draw a vertical line at a point that best approximates the participant's current level of EoE disease activity. A negative change from baseline indicates that disease activity decreased.
10. Distribution of Responses For The Patient Global Impression of Change (PGIC) Survey at The Final Treatment Evaluation [ Time Frame: Week 16 ]
    Participants evaluated the change in their dysphasia (food passing slowly/difficulty swallowing) since the start of the study (screening) by choosing 1 of 7 responses on the PGIC survey: much worse (-3), worse (-2), a little worse (-1), no change (0), a little better (1), better (2), or much better (3). The values reported are the percent of participants who chose that response.
11. Percent of Participants With Improved Symptoms on The Eosinophilic Esophagitis (EoE) Symptom Survey at The Final Treatment Period Evaluation [ Time Frame: Week 16 ]
    The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom ('Yes' to 'No'); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom ('No' to 'Yes').
12. Percent of Participants With No Change in Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation [ Time Frame: Week 16 ]
    The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom ('Yes' to 'No'); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom ('No' to 'Yes').
13. Percent of Participants With Worsened Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation [ Time Frame: Week 16 ]
    The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom ('Yes' to 'No'); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom ('No' to 'Yes').
14. Percent of Participants Without Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation [ Time Frame: Week 16 ]
    This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.
15. Percent of Participants With New Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation [ Time Frame: Week 16 ]
    This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.
16. Percent of Participants Who Were Symptom Responders on The DSQ+Pain Scale at The Final Treatment Period Evaluation [ Time Frame: Week 16 ]
    Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Question 1 (did you eat solid food) and Question 2 (did food pass slowly or get stuck). If the answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Question 3 (did you have to do anything to make the food go down or get relief) and Question 4 (extent to which the participant experienced pain while swallowing).The DSQ+pain response was defined as a >/= 30% and >/= 50% reduction from baseline in the combined score from Questions 2, 3, and 4. The 2-week DSQ+pain score was calculated by adding points from Questions 2, 3, and 4 and then taking the average of the available scores over each 2-week interval.
17. Percent of Days That Participants Reported That They Avoided Solid Food During The Baseline And Treatment Periods [ Time Frame: From 14 days prior to the baseline visit to the final treatment period evaluation ]
    Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Values were calculated for all the days that Question 1 was answered from 14 days prior to baseline visit up to the final treatment period evaluation.
18. Change From Baseline in The Scores of DSQ Question 1 During The Treatment Period [ Time Frame: Baseline, Weeks 8, 12, and 16 ]
    Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 1 is rated as Yes (score=0) or No (score=1); higher values indicate a worse outcome. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.
19. Change From Baseline in The Scores of DSQ Question 4 During The Treatment Period [ Time Frame: Baseline, Weeks 8, 12, and 16 ]
    Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 4 is rated as None, I had no pain (score=0), mild pain (score=1), moderate pain (score=2), severe pain (score=3), or very severe pain (score=4); 4 is the worst pain. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.

Eligibility Criteria

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Ages Eligible for Study:	11 Years to 40 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Males and Females, age 11-40
• Histologic evidence of EoE
• History of clinical symptoms of EoE including dysphagia
• Willing to continue with dietary, environmental or medical therapy
• Ability to read and understand english
• Written Consent

Exclusion Criteria:

• Any Medical condition that may compromise the safety of the subjects or interfere with the signs and symptoms of EoE
• Use of immunomodulatory therapy
• Current use of swallowed corticosteroids
• Esophageal strictures,varices or upper GI bleed
• Other current diseases of the GI tract
• Current viral infection or immunodeficiency condition
• Pregnancy
• Hypersensitivity to budesonide
• History of non compliance

Contacts and Locations

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Locations

United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
UCSD Rady Children's Hospital
San Diego, California, United States, 92123
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Georgia
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern Scool of Medicine
Chicago, Illinois, United States, 60611
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Center for Children's Digestive Health
Park Ridge, Illinois, United States, 60068
United States, Indiana
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Minnesota
The Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
The Cincinnati Center for Eosinophilic Disorders
Cincinnati, Ohio, United States, 45229
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Children's Center for Digestive Health
Greenville, South Carolina, United States, 29615
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah Healthcare
Salt Lake City, Utah, United States, 84132
United States, Virginia
Carilion Pediatric Gastroenterology
Roanoke, Virginia, United States, 24013

Sponsors and Collaborators

Shire

Investigators

Principal Investigator:	Amir Kagalwalla, MD	Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator:	Jeffrey Lewis, MD	Children's Center for Digestive Healthcare
Principal Investigator:	Jonathan Markowitz, MD	Children's Center for Digestive Health
Principal Investigator:	Samuel Nurko, MD	Boston Children’s Hospital
Principal Investigator:	John Wo, MD	Indiana University Health University Hospital
Principal Investigator:	Evan Dellon, MD	University of North Carolina, Chapel Hill
Principal Investigator:	T.S. Gunasekaran, MD	Center for Digestive Health
Principal Investigator:	Ikuo Hirano, MD	Northwestern School of Medicine
Principal Investigator:	Sandeep Gupta, MD	Riley Hospital for Children
Principal Investigator:	Brad Pasternak, MD	Phoenix Children's Hospital
Principal Investigator:	Mark Ellis, MD	Children's Hospital Orange County
Principal Investigator:	Kathyrn Peterson, MD	University of Utah Healthcare
Principal Investigator:	Gary Falk, MD	University of Pennsylvania
Principal Investigator:	John Leung, MD	Tufts Medical Center
Principal Investigator:	John Russo, MD	The Research Institute at Nationwide Children's Hospital
Principal Investigator:	Michael Hart, MD	Carilion Clinic
Principal Investigator:	Neal Leleiko, MD	Rhode Island Hospital
Principal Investigator:	Michael Vaezi, MD	Vanderbilt University Medical Center
Principal Investigator:	Rebecca Cherry, MD	UCSD
Principal Investigator:	Robert Kramer, MD	Children's Hospital Colorado
Principal Investigator:	David Katzka, MD	Mayo Clinic
Principal Investigator:	Keith Friedenberg, MD	Great Lakes Gastroenterology
Principal Investigator:	Ron Schey, MD	University of Iowa Hospital
Principal Investigator:	Yoram Elitsur, MD	University Physician & Surgeons (UP&S)
Principal Investigator:	Harvey Tatum, MD	Options Health Research, LLC
Principal Investigator:	Vincent Mukkada, MD	The Cincinnati Center for Eosinophilic Disorders

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dellon ES, Katzka DA, Collins MH, Hamdani M, Gupta SK, Hirano I; MP-101-06 Investigators. Budesonide Oral Suspension Improves Symptomatic, Endoscopic, and Histologic Parameters Compared With Placebo in Patients With Eosinophilic Esophagitis. Gastroenterology. 2017 Mar;152(4):776-786.e5. doi: 10.1053/j.gastro.2016.11.021. Epub 2016 Nov 23.

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01642212 History of Changes
Other Study ID Numbers:	MPI-101-06
First Posted:	July 17, 2012
Results First Posted:	December 7, 2015
Last Update Posted:	December 7, 2015
Last Verified:	March 2014

Keywords provided by Shire:

EoE

Additional relevant MeSH terms:

Esophagitis; Eosinophilic Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases	Budesonide; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists