Back to resultsThe Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
Primary Purpose
Milk Allergy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Milk Protein Extract Immunotherapy goal of 4mg/day
Milk Protein Extract Immunotherapy goal of 7mg/day
Milk Powder Immunotherapy goal dose 2000 mg/day
Milk Powder Immunotherapy goal dose 1000mg/day
Sponsored by
About this trial
This is an interventional treatment trial for Milk Allergy focused on measuring Food Allergy, Oral Immunotherapy, Immunoglobulin E
Eligibility Criteria
Inclusion Criteria:
- Are age 6 to 21 years
- Provide signed informed consent (by parent or legal guardian if the subject is a minor), and informed assent if applicable
- Have a history of symptomatic reactivity to cow's milk (i.e. Eczema, urticaria, upper or lower respiratory symptoms, GI disturbances, other rash or oral symptoms)
- Have a positive skin prick test (defined as wheal 3 mm ≥ negative control) and cow's milk- immunoglobulin E (IgE) > 0.35 kilo Immunoglobulin Units (kIU)/L
- Have a positive OFC to cow's milk at a cumulative dose of less than 184 milligrams of cow's milk intact protein (2,400 mg total milk protein).
- Are using appropriate birth control if subject is female and of child bearing age.
- Have self-injectable epinephrine (ie. EpiPen® or EpiPen Jr.®) available at home
Exclusion Criteria:
- Have a history of severe anaphylaxis defined as hypoxia (cyanosis or SpO2 ≤ 92% at any stage), hypotension, confusion, collapse, loss of consciousness; or incontinence
- Have a history of intubation related to asthma
- Tolerate more than 184 milligrams of intact cow's milk protein at initial OFC
- Are pregnant or lactating
- Have a viral Upper Respiratory Infection (URI) or gastroenteritis within 7 days of OFC (OFC needs to be rescheduled)
- Have pulmonary function tests <80% of predicted (FEV1) or clinical history consistent with more than moderate persistent asthma
- Are currently taking greater than medium dose inhaled corticosteroid (>400 mcg/day fluticasone or fluticasone equivalent if ≤ 12 years old or > 600 mcg/day if > 12 years old)
- Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges
- Have used systemic corticosteroids within 4 weeks prior to baseline visit
- Are receiving omalizumab, beta-blocker, Angiotensin Converting Enzyome (ACE) inhibitor or tricyclic antidepressant therapy
- Have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Have participated in any interventional study for treatment of a food allergy in the past 12 months
- Have a severe reaction at initial DBPCFC, defined as either:
Life-threatening anaphylaxis, or Reaction requiring hospitalization
Sites / Locations
- Johns Hopkins Hospital
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Sublingual Immunotherapy (SLIT)
SLIT/ Oral Immunotherpay (OIT) B
SLIT/ OIT A
Arm Description
These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year. Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year. Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year. Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years. Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Outcomes
Primary Outcome Measures
Change in CM-specific Immunogloblin E (IgE)
Cow's milk specific IgE was measured at baseline and after therapy (kUa/L)
Change in CM-specific Immunoglobulin G4 (IgG4)
Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L)
Change in End Point Skin Test
Allergen provoked skin test (mm)
Oral Food Challenge Threshold (OFC) Threshold
mg CM protein
Secondary Outcome Measures
Full Information
NCT ID
NCT00732654
First Posted
August 8, 2008
Last Updated
April 6, 2017
Sponsor
Johns Hopkins University
Collaborators
Duke University, Greer Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00732654
Brief Title
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
Official Title
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Duke University, Greer Laboratories
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Milk Allergy
Keywords
Food Allergy, Oral Immunotherapy, Immunoglobulin E
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sublingual Immunotherapy (SLIT)
Arm Type
Experimental
Arm Description
These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.
Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
Arm Title
SLIT/ Oral Immunotherpay (OIT) B
Arm Type
Experimental
Arm Description
These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Arm Title
SLIT/ OIT A
Arm Type
Experimental
Arm Description
These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Intervention Type
Drug
Intervention Name(s)
Milk Protein Extract Immunotherapy goal of 4mg/day
Intervention Description
Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Intervention Type
Drug
Intervention Name(s)
Milk Protein Extract Immunotherapy goal of 7mg/day
Intervention Description
Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
Intervention Type
Drug
Intervention Name(s)
Milk Powder Immunotherapy goal dose 2000 mg/day
Intervention Description
Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Intervention Type
Drug
Intervention Name(s)
Milk Powder Immunotherapy goal dose 1000mg/day
Intervention Description
Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Primary Outcome Measure Information:
Title
Change in CM-specific Immunogloblin E (IgE)
Description
Cow's milk specific IgE was measured at baseline and after therapy (kUa/L)
Time Frame
Change from baseline to after therapy (up to 18 months)
Title
Change in CM-specific Immunoglobulin G4 (IgG4)
Description
Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L)
Time Frame
Change from baseline to after therapy (up to 18 months)
Title
Change in End Point Skin Test
Description
Allergen provoked skin test (mm)
Time Frame
Change from baseline to after therapy (up to 18 months)
Title
Oral Food Challenge Threshold (OFC) Threshold
Description
mg CM protein
Time Frame
Change from baseline to after therapy (up to 18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are age 6 to 21 years
Provide signed informed consent (by parent or legal guardian if the subject is a minor), and informed assent if applicable
Have a history of symptomatic reactivity to cow's milk (i.e. Eczema, urticaria, upper or lower respiratory symptoms, GI disturbances, other rash or oral symptoms)
Have a positive skin prick test (defined as wheal 3 mm ≥ negative control) and cow's milk- immunoglobulin E (IgE) > 0.35 kilo Immunoglobulin Units (kIU)/L
Have a positive OFC to cow's milk at a cumulative dose of less than 184 milligrams of cow's milk intact protein (2,400 mg total milk protein).
Are using appropriate birth control if subject is female and of child bearing age.
Have self-injectable epinephrine (ie. EpiPen® or EpiPen Jr.®) available at home
Exclusion Criteria:
Have a history of severe anaphylaxis defined as hypoxia (cyanosis or SpO2 ≤ 92% at any stage), hypotension, confusion, collapse, loss of consciousness; or incontinence
Have a history of intubation related to asthma
Tolerate more than 184 milligrams of intact cow's milk protein at initial OFC
Are pregnant or lactating
Have a viral Upper Respiratory Infection (URI) or gastroenteritis within 7 days of OFC (OFC needs to be rescheduled)
Have pulmonary function tests <80% of predicted (FEV1) or clinical history consistent with more than moderate persistent asthma
Are currently taking greater than medium dose inhaled corticosteroid (>400 mcg/day fluticasone or fluticasone equivalent if ≤ 12 years old or > 600 mcg/day if > 12 years old)
Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges
Have used systemic corticosteroids within 4 weeks prior to baseline visit
Are receiving omalizumab, beta-blocker, Angiotensin Converting Enzyome (ACE) inhibitor or tricyclic antidepressant therapy
Have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring therapy (e.g., heart disease, diabetes)
Have participated in any interventional study for treatment of a food allergy in the past 12 months
Have a severe reaction at initial DBPCFC, defined as either:
Life-threatening anaphylaxis, or Reaction requiring hospitalization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wood, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
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