Clinical trial NCT00732654: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Milk Allergy
Keywords: Food Allergy
Oral Immunotherapy
Immunoglobulin E
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Duke University
name: Greer Laboratories
First posted: 2008-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in CM-specific Immunogloblin E (IgE)
timeFrame: Change from baseline to after therapy (up to 18 months)
measure: Change in CM-specific Immunoglobulin G4 (IgG4)
timeFrame: Change from baseline to after therapy (up to 18 months)
measure: Change in End Point Skin Test
timeFrame: Change from baseline to after therapy (up to 18 months)
measure: Oral Food Challenge Threshold (OFC) Threshold
timeFrame: Change from baseline to after therapy (up to 18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Johns Hopkins University
name: Robert Wood, MD
role: PRINCIPAL_INVESTIGATOR
References: