Overview

This trial is active, not recruiting.

Condition milk allergy
Treatments milk protein extract immunotherapy, milk powder immunotherapy
Phase phase 1/phase 2
Sponsor Robert A. Wood
Collaborator Duke University
Start date August 2008
End date June 2010
Trial size 30 participants
Trial identifier NCT00732654, NCT00014511

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 protein extract immunotherapy
Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
milk powder immunotherapy
Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
(Experimental)
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 protein extract immunotherapy
Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
milk powder immunotherapy
Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
(Experimental)
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.

Primary Outcomes

Measure
The primary endpoint is clinical response to treatment, defined as (1) tolerating ten times the initial oral food challenge threshold dose, OR (2) tolerating the maximum oral food challenge dose at the oral food challenge, at completion of immunotherapy.
time frame: Approximately 1 1/2 years.

Secondary Outcomes

Measure
The proportion of patients who maintain a clinical response after withdrawal of treatment for one week.
time frame: Approximately 1 1/2 years.
The proportion of patients who maintain a clinical response after withdrawal of treatment for six weeks.
time frame: Approximately 1 1/2 years.
Incidence of all serious adverse events during the study
time frame: Approximately 1 1/2 years.
Incidence of all adverse events during the study.
time frame: Approximately 1 1/2 years.

Eligibility Criteria

Male or female participants from 6 years up to 21 years old.

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-IgE > 0.35 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 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, 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

Additional Information

Official title The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
Principal investigator Robert Wood, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Johns Hopkins University.