Phase 2
N=20
A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
Milk Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT00465569 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: The Median Milk Threshold Dose Inducing a Reaction — 40; 40; 5100; 0 miligrams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cow's milk powder (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Median Milk Threshold Dose Inducing a Reaction |
40; 40; 5100; 0 | — |
| SECONDARY Changes in Cow Milk-IgE |
8; -5 | — |
| SECONDARY Changes in Cow Milk Immunoglobulin G4 (IgG4) |
767; 14 | — |
Summary
The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
Eligibility Criteria
Inclusion Criteria
- Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable
- Age 6 to 21 years
- Must have history of symptomatic reactivity to cow's milk (eczema, urticaria, upper/lower resp., GI, other associated rash, oral symptoms)
- History of positive skin prick test (wheal >/= histamine control) or milk-Immunoglobulin E (IgE)>0.35 kilounits per liter (kU/L)
- Positive DBPCFC
- All females of child bearing age must be using appropriate birth control
Exclusion Criteria
- History of anaphylaxis requiring hospitalization
- History of intubation related to asthma
- Has the ability to tolerate >2.4gram of milk protein at initial DBPCFC
- Has a history of allergy to any component of vehicle
- Pregnancy (need negative test)
- Viral upper respiratory infection (URI) or gastroenteritis within 7days of OFC (OFC needs to be rescheduled)
- Has pulmonary function tests 400mcg/day fluticasone or fluticasone equivalent if 600mcg/day if >12 years old)
- Antihistamine within 1 week prior to skin testing or food challenges (Skin testing and/or food challenge needs to be rescheduled)
- Systemic corticosteroid within 4 weeks prior to baseline visit
- Receiving omalizumab, beta-blocker, Angiotensin-converting enzyme (ACE) inhibitor or tricyclic antidepressant therapy
- Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Participation in any interventional study for treatment of a food allergy in the past 12 months
- Severe reaction at initial DBPCFC, defined as:
i. Life-threatening anaphylaxis ii. Requires overnight hospitalization
Data sourced from ClinicalTrials.gov (NCT00465569). 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.