Phase 2 N=30 Randomized Treatment

The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy

Milk Allergy

Bottom Line

View on ClinicalTrials.gov: NCT00732654 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Change in CM-specific Immunogloblin E (IgE) — 0.8; -13.5; -9.4 kUa/L

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Milk Protein Extract Immunotherapy goal of 4mg/day (Drug); Milk Protein Extract Immunotherapy goal of 7mg/day (Drug); Milk Powder Immunotherapy goal dose 2000 mg/day (Drug); Milk Powder Immunotherapy goal dose 1000mg/day (Drug)
Age: Pediatric, Adult · 6+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in CM-specific Immunogloblin E (IgE)	0.8; -13.5; -9.4	—
PRIMARY Change in CM-specific Immunoglobulin G4 (IgG4)	9.9; 157.2; 31.8	—
PRIMARY Change in End Point Skin Test	-3.1; -3; -2.5	—
PRIMARY Oral Food Challenge Threshold (OFC) Threshold	2458; 8089; 7989	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00732654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.