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

NCT ID: NCT00732654

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2012-06-30

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.

Conditions

Milk Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sublingual Immunotherapy (SLIT)

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.

Group Type: EXPERIMENTAL

Milk Protein Extract Immunotherapy goal of 4mg/day

Intervention Type: DRUG

Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

Milk Protein Extract Immunotherapy goal of 7mg/day

Intervention Type: DRUG

Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.

SLIT/ Oral Immunotherpay (OIT) B

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.

Group Type: EXPERIMENTAL

Milk Protein Extract Immunotherapy goal of 4mg/day

Intervention Type: DRUG

Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

Milk Powder Immunotherapy goal dose 1000mg/day

Intervention Type: DRUG

Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

SLIT/ OIT A

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.

Group Type: EXPERIMENTAL

Milk Protein Extract Immunotherapy goal of 4mg/day

Intervention Type: DRUG

Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

Milk Powder Immunotherapy goal dose 2000 mg/day

Intervention Type: DRUG

Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.

Interventions

Milk Protein Extract Immunotherapy goal of 4mg/day

Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

Intervention Type: DRUG

Milk Protein Extract Immunotherapy goal of 7mg/day

Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.

Intervention Type: DRUG

Milk Powder Immunotherapy goal dose 2000 mg/day

Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.

Intervention Type: DRUG

Milk Powder Immunotherapy goal dose 1000mg/day

Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Greer Laboratories

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Wood, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

NA_00732654

Identifier Type: -

Identifier Source: org_study_id