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

NCT00465569 | Completed Phase 1 Results DMC

• 1 other identifier: NA_00002102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Milk Hypersensitivity

Keywords

Food Allergy; Oral Immunotherapy; Immunoglobulin E

Outcome Measures

Primary Outcomes (1)

• The Median Milk Threshold Dose Inducing a Reaction

  Baseline and 23 weeks

Secondary Outcomes (2)

• Changes in Cow Milk-IgE

  Baseline and 23 weeks

• Changes in Cow Milk Immunoglobulin G4 (IgG4)

  Baseline and 23 weeks

Study Arms (2)

Active Treatment

EXPERIMENTAL

Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians

Drug: cow's milk powder

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

cow's milk powder DRUG

Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks

Active Treatment

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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-Immunoglobulin E (IgE)\>0.35 kilounits per liter (kU/L)
• Positive DBPCFC
• All females of child bearing age must be using appropriate birth control

You may not qualify if:

• 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 upper respiratory infection (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 \>12 years old)
• 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, Angiotensin-converting enzyme (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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Duke University: collaborator

Study Sites (2)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, Steele PH, Pons L, Helm RM, Lee LA, Burks AW. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007 Jan;119(1):199-205. doi: 10.1016/j.jaci.2006.09.016. Epub 2006 Oct 27.

  PMID: 17208602 BACKGROUND

• Meglio P, Bartone E, Plantamura M, Arabito E, Giampietro PG. A protocol for oral desensitization in children with IgE-mediated cow's milk allergy. Allergy. 2004 Sep;59(9):980-7. doi: 10.1111/j.1398-9995.2004.00542.x.

  PMID: 15291907 BACKGROUND

• Enrique E, Pineda F, Malek T, Bartra J, Basagana M, Tella R, Castello JV, Alonso R, de Mateo JA, Cerda-Trias T, San Miguel-Moncin Mdel M, Monzon S, Garcia M, Palacios R, Cistero-Bahima A. Sublingual immunotherapy for hazelnut food allergy: a randomized, double-blind, placebo-controlled study with a standardized hazelnut extract. J Allergy Clin Immunol. 2005 Nov;116(5):1073-9. doi: 10.1016/j.jaci.2005.08.027. Epub 2005 Oct 3.

  PMID: 16275379 BACKGROUND

• Skripak JM, Nash SD, Rowley H, Brereton NH, Oh S, Hamilton RG, Matsui EC, Burks AW, Wood RA. A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. J Allergy Clin Immunol. 2008 Dec;122(6):1154-60. doi: 10.1016/j.jaci.2008.09.030. Epub 2008 Oct 25.

  PMID: 18951617 RESULT

MeSH Terms

Conditions

Milk Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Robert A. Wood, MD
• Organization: Johns Hopkins University

rwood@jhmi.edu

410-955-5883

Study Officials

• Robert A Wood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: August 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 20, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-04

Locations

US (2)