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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732654
First Posted: August 12, 2008
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Duke University
Greer Laboratories
Information provided by (Responsible Party):
Johns Hopkins University
August 8, 2008
August 12, 2008
March 28, 2016
May 15, 2017
May 15, 2017
August 2008
June 2010   (Final data collection date for primary outcome measure)
  • Change in CM-specific Immunogloblin E (IgE) [ Time Frame: Change from baseline to after therapy (up to 18 months) ]
    Cow's milk specific IgE was measured at baseline and after therapy (kUa/L)
  • Change in CM-specific Immunoglobulin G4 (IgG4) [ Time Frame: Change from baseline to after therapy (up to 18 months) ]
    Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L)
  • Change in End Point Skin Test [ Time Frame: Change from baseline to after therapy (up to 18 months) ]
    Allergen provoked skin test (mm)
  • Oral Food Challenge Threshold (OFC) Threshold [ Time Frame: Change from baseline to after therapy (up to 18 months) ]
    mg CM protein
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. ]
Complete list of historical versions of study NCT00732654 on ClinicalTrials.gov Archive Site
Not Provided
  • 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. ]
Not Provided
Not Provided
 
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Milk Allergy
  • Drug: 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.
  • 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.
  • 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.
  • 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.
  • Experimental: 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.

    Interventions:
    • Drug: Milk Protein Extract Immunotherapy goal of 4mg/day
    • Drug: Milk Protein Extract Immunotherapy goal of 7mg/day
  • Experimental: 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.

    Interventions:
    • Drug: Milk Protein Extract Immunotherapy goal of 4mg/day
    • Drug: Milk Powder Immunotherapy goal dose 1000mg/day
  • Experimental: 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.

    Interventions:
    • Drug: Milk Protein Extract Immunotherapy goal of 4mg/day
    • Drug: Milk Powder Immunotherapy goal dose 2000 mg/day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2012
June 2010   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
6 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00732654
NA_00732654
Yes
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
  • Duke University
  • Greer Laboratories
Principal Investigator: Robert Wood, MD Johns Hopkins University
Johns Hopkins University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP