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

April 23, 2007
April 27, 2012
August 2006
June 2008   (final data collection date for primary outcome measure)
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 ]
The percentage of patients who can tolerate four times the initial OFC threshold dose or the maximum OFC dose of 8 grams after therapy.
Complete list of historical versions of study NCT00465569 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of protocol-defined severe hypersensitivity reactions during the study
  • Incidence of all serious adverse events during the study
  • Incidence of all adverse events
  • To assess for any changes in milk-IgE, milk-IgG4, and skin test reactivity during OIT and as milk allergy persists or resolves.
Not Provided
Not Provided
 
A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Milk Hypersensitivity
Drug: cow's milk powder
Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2008
June 2008   (final data collection date for primary outcome measure)

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

Both
6 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00465569
NA_00002102
Yes
Robert A. Wood, Johns Hopkins University
Robert A. Wood
Duke University
Principal Investigator: Robert A Wood, MD The Johns Hopkins University School of Medicine
Johns Hopkins University
April 2012

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