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A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Robert A. Wood, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00465569
First received: April 23, 2007
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.


Condition Intervention Phase
Milk Hypersensitivity
Drug: cow's milk powder
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The percentage of patients who can tolerate four times the initial OFC threshold dose or the maximum OFC dose of 8 grams after therapy. [ Time Frame: Approximately 23 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of protocol-defined severe hypersensitivity reactions during the study [ Time Frame: 23 - 66 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of all serious adverse events during the study [ Time Frame: 23-66 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of all adverse events [ Time Frame: 23-66 weeks ] [ Designated as safety issue: Yes ]
  • To assess for any changes in milk-IgE, milk-IgG4, and skin test reactivity during OIT and as milk allergy persists or resolves. [ Time Frame: 23-66 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cow's milk powder
    Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks
Detailed Description:

This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited from 2 sites (Johns Hopkins and Duke University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk. Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC. Those in the treatment group who are not desensitized will return to strict avoidance. Those in placebo group will be offered to begin treatment or continue with strict milk avoidance. Symptom and diet information will be collected initially and at regular intervals. Bloodwork, skin prick tests (SPTs), pulmonary function tests (PFTs), and oral secretion samples will be done initially and at periodic intervals.

  Eligibility

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

Inclusion Criteria:

  • Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable
  • Age 6 to 21 years
  • Must have history of symptomatic reactivity to cow's milk (eczema, urticaria, upper/lower resp., GI, other associated rash, oral symptoms)
  • History of positive skin prick test (wheal >/= histamine control) or milk-IgE>0.35 kIU/L
  • Positive DBPCFC
  • All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

  • History of anaphylaxis requiring hospitalization
  • History of intubation related to asthma
  • Has the ability to tolerate >2.4gram of milk protein at initial DBPCFC
  • Has a history of allergy to any component of vehicle
  • Pregnancy (need negative test)
  • Viral URI or gastroenteritis within 7days of OFC (OFC needs to be rescheduled)
  • Has pulmonary function tests <80% of predicted (FEV1) or clinical history consistent with moderate persistent asthma
  • Currently taking greater than medium dose inhaled corticosteroid (>400mcg/day fluticasone or fluticasone equivalent if </=12yo or >600mcg/day if >12y/o)
  • Antihistamine within 1 week prior to skin testing or food challenges (Skin testing and/or food challenge needs to be rescheduled)
  • Systemic corticosteroid within 4 weeks prior to baseline visit
  • Receiving omalizumab, beta-blocker, ACE inhibitor or tricyclic antidepressant therapy
  • Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
  • Participation in any interventional study for treatment of a food allergy in the past 12 months
  • Severe reaction at initial DBPCFC, defined as:

    i. Life-threatening anaphylaxis ii. Requires overnight hospitalization

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465569

Locations
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Robert A. Wood
Duke University
Investigators
Principal Investigator: Robert A Wood, MD The Johns Hopkins University School of Medicine
  More Information

Publications:
Responsible Party: Robert A. Wood, Professor of Pediatrics- Allergy and Immunology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00465569     History of Changes
Other Study ID Numbers: NA_00002102
Study First Received: April 23, 2007
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Food Allergy
Oral Immunotherapy
Immunoglobulin E

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on November 19, 2014