Clinical trial NCT02216175: Improving the Safety of Oral Immunotherapy for Cow's Milk Allergy
Official title: Phase 2/3 Clinical Trial to Assess the Effect of a Sublingual Treatment Phase Prior to Oral Immunotherapy in Children With Cow's Milk Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Keywords: Cow's milk allergy
Desensitisation
Safety
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: JP Moulton Charitable Foundation
name: Sociedad Española de Alergología e Inmunología
name: Sociedad Española de Inmunología Clínica, Alergología y Asma Pediátrica
First posted: 2014-08-13
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Allergy to cow's milk is the most common food allergy affecting children. There is currently no accepted routine clinical therapy to cure milk allergy. Recently studies have attempted to induce desensitisation using small daily doses of cow's milk, predominantly by the oral route (oral immunotherapy, OIT). Although this therapy works for some people, its effects are not generally long lasting and it is associated with significant side effects during protocol, including potentially life-threatening allergic reactions.

Pilot data suggests that sublingual immunotherapy (SLIT, where allergen is held under the tongue, rather than swallowed) can also induce a degree of desensitisation, but with fewer adverse events. However, the degree of desensitisation induced appears to be lower than that with oral immunotherapy.

The investigators wish to determine whether a sublingual pretreatment phase can improve the safety of conventional OIT in cow's milk allergy.


Eligibility criteria: Inclusion Criteria:

1. Allergic to 1.44g CM protein (approx. 40ml fresh milk) or less, at DBPCFC prior to randomisation
2. Informed consent of parent/legal guardian, patient assent where possible

Exclusion Criteria:

1. Required previous admission to an intensive care unit for management of an allergic reaction.
2. Significant symptoms of non---IgE---mediated CM allergy within the previous 12 months.
3. Children with a past history of CM allergy currently consuming CM-containing products other than extensively--heated milk in baked foods (e.g. biscuits, cakes).
4. Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON consensus), or asthma requiring treatment with \>5 days oral corticosteroids within the previous 3 months.
5. Moderate---severe eczema, defined as requiring more than once daily application of 1% hydrocortisone as maintenance treatment despite appropriate use of emollients (eczema is not otherwise an exclusion criteria)
6. Clinically significant chronic illness (other than asthma, rhinitis or eczema)
7. History of symptoms of eosinophilic oesophagitis, irrespective of cause
8. Undergoing specific immunotherapy to another allergen and within the first year of treatment.
9. Receiving anti--IgE therapy, oral immunosuppressants, beta---blocker or ACE inhibitor.
10. Pregnancy
11. Unwilling or unable to fulfil study requirements

Primary outcomes:
measure: Adverse events in participants
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 1 year
measure: Eliciting dose(mg cow's milk protein) at DBPCFC after each phase of immunotherapy
timeFrame: 1 year
measure: Change in Health-related quality of life (HRQL) from baseline - assessed using FAQLQ - after each phase of immunotherapy
timeFrame: 15 months
measure: Change in Health-related quality of life (HRQL) from baseline - assessed using FAIM - after each phase of immunotherapy
timeFrame: 15 months
measure: Change in Health-related quality of life (HRQL) from baseline - assessed using Change in EQ-5D from baseline - after each phase of immunotherapy
timeFrame: 15 months
measure: Change in self-efficacy after each phase of immunotherapy
timeFrame: 15 months
measure: Immunological outcomes
timeFrame: 12 months
measure: Immunological outcome: skin prick test
timeFrame: 12 months
measure: Immunological outcomes: Allergen-specific IgE
timeFrame: 12 months
measure: Peptide microarray
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Niño Jesús Hospital
city: London
country: United Kingdom
facility: Imperial College London / Imperial College Healthcare NHS Trust
Study officials:
References:
citation: Turner PJ, Duca B, Chastell SA, Alvarez O, Bazire R, Vazquez-Ortiz M, Rodriguez Del Rio P. IgE-sensitization predicts threshold but not anaphylaxis during oral food challenges to cow's milk. Allergy. 2022 Apr;77(4):1291-1293. doi: 10.1111/all.15195. Epub 2021 Dec 14. No abstract available.