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

NCT00732654 | Completed Phase 1 Results DMC

• 1 other identifier: NA_00732654
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Keywords

Food Allergy; Oral Immunotherapy; Immunoglobulin E

Outcome Measures

Primary Outcomes (4)

• Change in CM-specific Immunogloblin E (IgE)

  Cow's milk specific IgE was measured at baseline and after therapy (kUa/L)

  Change from baseline to after therapy (up to 18 months)

• Change in CM-specific Immunoglobulin G4 (IgG4)

  Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L)

  Change from baseline to after therapy (up to 18 months)

• Change in End Point Skin Test

  Allergen provoked skin test (mm)

  Change from baseline to after therapy (up to 18 months)

• Oral Food Challenge Threshold (OFC) Threshold

  mg CM protein

  Change from baseline to after therapy (up to 18 months)

Study Arms (3)

Sublingual Immunotherapy (SLIT)

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.

Drug: Milk Protein Extract Immunotherapy goal of 4mg/day; Drug: Milk Protein Extract Immunotherapy goal of 7mg/day

SLIT/ Oral Immunotherpay (OIT) B

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

Drug: Milk Protein Extract Immunotherapy goal of 4mg/day; Drug: Milk Powder Immunotherapy goal dose 1000mg/day

SLIT/ OIT A

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 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.

Drug: Milk Protein Extract Immunotherapy goal of 4mg/day; Drug: Milk Powder Immunotherapy goal dose 2000 mg/day

Interventions

Milk Protein Extract Immunotherapy goal of 4mg/day DRUG

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

SLIT/ OIT A; SLIT/ Oral Immunotherpay (OIT) B; Sublingual Immunotherapy (SLIT)

Milk Protein Extract Immunotherapy goal of 7mg/day DRUG

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

Sublingual Immunotherapy (SLIT)

Milk Powder Immunotherapy goal dose 2000 mg/day DRUG

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

SLIT/ OIT A

Milk Powder Immunotherapy goal dose 1000mg/day DRUG

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

SLIT/ Oral Immunotherpay (OIT) B

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Duke University: collaborator
• Greer Laboratories: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Milk Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Please refer to the links section, it contains a link to the publication of this research study in the Journal of Allergy and Clinical Immunology

Results Point of Contact

• Title: Corinne Keet
• Organization: Johns Hopkins University

pediatricallergy@jhmi.edu

4109555883

Study Officials

• Robert Wood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2012
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-04

Locations

US (2)