A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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) |
-
Drug: cow's milk powder
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 |
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| United States, Maryland | |
| The Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| 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 Immune System Diseases Food Hypersensitivity Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on May 23, 2013