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Improving the Safety of Oral Immunotherapy for Cow's Milk Allergy (SOCMA)

Primary Purpose

Food Allergy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SLIT to cow's milk
Low dose OIT
Conventional OIT to cow's milk
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy focused on measuring Cow's milk allergy, Desensitisation, Safety

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Niño Jesús Hospital
  • Imperial College London / Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

SLIT followed by Conventional OIT

Conventional OIT

Delayed start OIT

Arm Description

Participants will receive up to 7 months of SLIT followed by 6 months conventional OIT to cow's milk

Participants will receive up to 7 months of low dose OIT, followed by 6 months conventional OIT to cow's milk

Participants will receive up to 7 months placebo, followed by 6 months conventional OIT to cow's milk

Outcomes

Primary Outcome Measures

Adverse events in participants
Proportion of participants experiencing adverse events (excluding mild, non-transient symptoms) conventional OIT to cow's milk in phase 2, in those who have received SLIT pretreatment compared to placebo.

Secondary Outcome Measures

Incidence of adverse events
Incidence of adverse events experienced (including rate of withdrawals, and anaphylaxis/adrenaline use during updosing)
Eliciting dose(mg cow's milk protein) at DBPCFC after each phase of immunotherapy
Efficacy defined at Double-blind, placebo-controlled food challenge (DBPCFC) as the proportion of study participants experiencing: No symptoms (or only mild transient symptoms) to 8 grams CM protein (approx. 250mls fresh milk) ("Complete desensitisation") No symptoms (or only mild transient symptoms) to at least 1.4 grams CM protein (approx. 45mls fresh milk) ("Partial desensitisation") At least a 10--fold increase in eliciting dose (defined as the lowest dose which elicits objective symptoms or signs at challenge). …at 6 and 12 months in the different treatment groups
Change in Health-related quality of life (HRQL) from baseline - assessed using FAQLQ - after each phase of immunotherapy
Change in HRQL measures at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire: - Food Allergy Quality of Life Questionnaires (FAQLQ)
Change in Health-related quality of life (HRQL) from baseline - assessed using FAIM - after each phase of immunotherapy
Change in HRQL measures at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire: - Food Allergy Independent Measure (FAIM)
Change in Health-related quality of life (HRQL) from baseline - assessed using Change in EQ-5D from baseline - after each phase of immunotherapy
Change in HRQL measures at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire: - EQ-5D - a standardized instrument for use as a measure of health outcome.
Change in self-efficacy after each phase of immunotherapy
Change in self-efficacy at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using validated questionnaire.
Immunological outcomes
Change in skin prick test wheal (mm), end-point titration skin prick test, allergen-specific IgE (KuA/l) between baseline and post immunotherapy
Immunological outcome: skin prick test
Change in skin prick test wheal (mm) and end-point titration skin prick test between baseline and post immunotherapy
Immunological outcomes: Allergen-specific IgE
Change in allergen-specific IgE (KuA/l) between baseline and post immunotherapy
Peptide microarray
Trend in CM-peptide binding during OIT

Full Information

First Posted
August 7, 2014
Last Updated
January 14, 2023
Sponsor
Imperial College London
Collaborators
JP Moulton Charitable Foundation, Sociedad Española de Alergología e Inmunología, Sociedad Española de Inmunología Clínica, Alergología y Asma Pediátrica
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1. Study Identification

Unique Protocol Identification Number
NCT02216175
Brief Title
Improving the Safety of Oral Immunotherapy for Cow's Milk Allergy
Acronym
SOCMA
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
January 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imperial College London
Collaborators
JP Moulton Charitable Foundation, Sociedad Española de Alergología e Inmunología, Sociedad Española de Inmunología Clínica, Alergología y Asma Pediátrica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
Cow's milk allergy, Desensitisation, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLIT followed by Conventional OIT
Arm Type
Experimental
Arm Description
Participants will receive up to 7 months of SLIT followed by 6 months conventional OIT to cow's milk
Arm Title
Conventional OIT
Arm Type
Active Comparator
Arm Description
Participants will receive up to 7 months of low dose OIT, followed by 6 months conventional OIT to cow's milk
Arm Title
Delayed start OIT
Arm Type
Placebo Comparator
Arm Description
Participants will receive up to 7 months placebo, followed by 6 months conventional OIT to cow's milk
Intervention Type
Other
Intervention Name(s)
SLIT to cow's milk
Intervention Description
Sublingual immunotherapy
Intervention Type
Other
Intervention Name(s)
Low dose OIT
Intervention Description
Oral Immunotherapy (low dose)
Intervention Type
Other
Intervention Name(s)
Conventional OIT to cow's milk
Intervention Description
Oral Immunotherapy
Primary Outcome Measure Information:
Title
Adverse events in participants
Description
Proportion of participants experiencing adverse events (excluding mild, non-transient symptoms) conventional OIT to cow's milk in phase 2, in those who have received SLIT pretreatment compared to placebo.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Incidence of adverse events experienced (including rate of withdrawals, and anaphylaxis/adrenaline use during updosing)
Time Frame
1 year
Title
Eliciting dose(mg cow's milk protein) at DBPCFC after each phase of immunotherapy
Description
Efficacy defined at Double-blind, placebo-controlled food challenge (DBPCFC) as the proportion of study participants experiencing: No symptoms (or only mild transient symptoms) to 8 grams CM protein (approx. 250mls fresh milk) ("Complete desensitisation") No symptoms (or only mild transient symptoms) to at least 1.4 grams CM protein (approx. 45mls fresh milk) ("Partial desensitisation") At least a 10--fold increase in eliciting dose (defined as the lowest dose which elicits objective symptoms or signs at challenge). …at 6 and 12 months in the different treatment groups
Time Frame
1 year
Title
Change in Health-related quality of life (HRQL) from baseline - assessed using FAQLQ - after each phase of immunotherapy
Description
Change in HRQL measures at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire: - Food Allergy Quality of Life Questionnaires (FAQLQ)
Time Frame
15 months
Title
Change in Health-related quality of life (HRQL) from baseline - assessed using FAIM - after each phase of immunotherapy
Description
Change in HRQL measures at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire: - Food Allergy Independent Measure (FAIM)
Time Frame
15 months
Title
Change in Health-related quality of life (HRQL) from baseline - assessed using Change in EQ-5D from baseline - after each phase of immunotherapy
Description
Change in HRQL measures at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire: - EQ-5D - a standardized instrument for use as a measure of health outcome.
Time Frame
15 months
Title
Change in self-efficacy after each phase of immunotherapy
Description
Change in self-efficacy at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using validated questionnaire.
Time Frame
15 months
Title
Immunological outcomes
Description
Change in skin prick test wheal (mm), end-point titration skin prick test, allergen-specific IgE (KuA/l) between baseline and post immunotherapy
Time Frame
12 months
Title
Immunological outcome: skin prick test
Description
Change in skin prick test wheal (mm) and end-point titration skin prick test between baseline and post immunotherapy
Time Frame
12 months
Title
Immunological outcomes: Allergen-specific IgE
Description
Change in allergen-specific IgE (KuA/l) between baseline and post immunotherapy
Time Frame
12 months
Title
Peptide microarray
Description
Trend in CM-peptide binding during OIT
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Allergic to 1.44g CM protein (approx. 40ml fresh milk) or less, at DBPCFC prior to randomisation Informed consent of parent/legal guardian, patient assent where possible Exclusion Criteria: Required previous admission to an intensive care unit for management of an allergic reaction. Significant symptoms of non---IgE---mediated CM allergy within the previous 12 months. 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). 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. 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) Clinically significant chronic illness (other than asthma, rhinitis or eczema) History of symptoms of eosinophilic oesophagitis, irrespective of cause Undergoing specific immunotherapy to another allergen and within the first year of treatment. Receiving anti--IgE therapy, oral immunosuppressants, beta---blocker or ACE inhibitor. Pregnancy Unwilling or unable to fulfil study requirements
Facility Information:
Facility Name
Niño Jesús Hospital
City
Madrid
Country
Spain
Facility Name
Imperial College London / Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34874567
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.
Results Reference
derived

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Improving the Safety of Oral Immunotherapy for Cow's Milk Allergy

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