The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy - Full Text View

Sponsors and Collaborators:	Johns Hopkins University Duke University Greer Laboratories
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00732654

Purpose

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.

Condition	Intervention	Phase
Milk Allergy	Drug: Milk Protein Extract Immunotherapy Drug: Milk Powder Immunotherapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of patients who maintain a clinical response after withdrawal of treatment for one week. [ Time Frame: Approximately 1 1/2 years. ] [ Designated as safety issue: No ]
The proportion of patients who maintain a clinical response after withdrawal of treatment for six weeks. [ Time Frame: Approximately 1 1/2 years. ] [ Designated as safety issue: No ]
Incidence of all serious adverse events during the study [ Time Frame: Approximately 1 1/2 years. ] [ Designated as safety issue: Yes ]
Incidence of all adverse events during the study. [ Time Frame: Approximately 1 1/2 years. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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.	Drug: Milk Protein Extract Immunotherapy Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks. Drug: Milk Powder Immunotherapy Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
2: 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.	Drug: Milk Protein Extract Immunotherapy Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks. Drug: Milk Powder Immunotherapy Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
3: 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.	Drug: Milk Protein Extract Immunotherapy Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.

Eligibility

Ages Eligible for Study:	6 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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-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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732654

Locations

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Johns Hopkins University

Duke University

Greer Laboratories

Investigators

Principal Investigator:

Robert Wood, MD

Johns Hopkins

More Information

No publications provided

Responsible Party:	Johns Hopkins School of Medicine ( Robert Wood M.D. )
Study ID Numbers:	NCT00014511
Study First Received:	August 8, 2008
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00732654 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Food Allergy
Oral Immunotherapy
Immunoglobulin E

Study placed in the following topic categories:

Antibodies
Food Hypersensitivity
Hypersensitivity

Milk Hypersensitivity
Hypersensitivity, Immediate
Immunoglobulins

Additional relevant MeSH terms:

Food Hypersensitivity
Hypersensitivity
Immune System Diseases
Milk Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 26, 2009