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

Milk Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00732654
• Other study ID #: NCT00014511
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: August 8, 2008
• Last updated: March 29, 2012
• Start date: August 2008
• Est. completion date: June 2015

Study information

• Verified date: March 2012
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersensitivity
• Milk Allergy
• Milk Hypersensitivity

Intervention

Drug:
• Milk Protein Extract Immunotherapy
Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
• Milk Protein Extract Immunotherapy
Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
• 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 Powder Immunotherapy
Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Duke University	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Robert A. Wood	Duke University, Greer Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Approximately 1 1/2 years.	No
Secondary	The proportion of patients who maintain a clinical response after withdrawal of treatment for one week.		Approximately 1 1/2 years.	No
Secondary	The proportion of patients who maintain a clinical response after withdrawal of treatment for six weeks.		Approximately 1 1/2 years.	No
Secondary	Incidence of all serious adverse events during the study		Approximately 1 1/2 years.	Yes
Secondary	Incidence of all adverse events during the study.		Approximately 1 1/2 years.	Yes