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Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study

ConditionsFood Allergy in ChildrenMilk AllergyEgg Allergy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age6-16
SponsorPablo Rodríguez del Rio

About this trial

This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 6 to 16 years old

sIgE levels to milk 0.35 to 35kUA/L for milk allergic subjects and egg 0.35 to 35kUA/L for egg allergic subjects

Entry DBPCFC discrete milk eliciting dose (ED)≥ 22.2mg of milk protein and discrete egg ED≥18.5mg of egg protein, that are the population-based reference values for the ED20

Having a mild to moderate food allergy severity per DEFASE score (<13 points)

Disqualifiers

sIgE levels to milk >35kUA/L for milk allergic subjects and egg > 35kUA/L for milk allergic subjects

Entry DBPCFC discrete milk ED<22.2mg of milk protein or discrete egg ED<18.5mg of egg protein

Entry DBPCFC discrete ED for milk>2112mg of milk protein (cumulative amount of 4193,7mg of milk protein) and egg discrete ED>1560mg of egg protein (cumulative amount of 3110.8mg of egg protein)

Having severe food allergy per DEFASE score (≥13 points)

Trial design

Design model

Parallel

Treatments tested in this trial

  • "Rush" regimen

    Biological/Vaccine

    The "rush" regimen consists of the administration of several incremental doses daily, every day, over the first week of the Induction Phase (Part 1)

  • "Conventional" regimen

    Biological/Vaccine

    The "conventional" regimen consists of the administration of only one incremental dose every 2 weeks, throughout all the Induction Phase (Part 1)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Rush protocolExperimental treatment 1 intervention
Group B: Conventional protocolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of adverse events with an oFASS5 severity ≥2 occurred until Induction Phase (Part 1) completion at the hospital setting per subject in both groups, rush vs conventional

Time frame
Throughout the Induction Phase (Part 1), 1 week up to 7 months
2

Proportion of subjects completing the Induction Phase (Part 1) in both groups (rush vs conventional) at the end of study (7 months of treatment)

Time frame
End of study (7 months of treatment)

Secondary outcomes

1

Number of adverse events with an oFASS5 severity ≥2 reported until Induction Phase (Part 1) completion at home and hospital setting per subject in both groups, rush vs conventional

Time frame
Throughout the Induction Phase (Part 1), 1 week up to 7 months
2

Number of anaphylaxis events reported until Induction Phase (Part 1) completion at home and hospital setting per subject in both groups, rush vs conventional

Time frame
Throughout the Induction Phase (Part 1), 1 week up to 7 months
3

Comparison of the median threshold change between baseline double blind placebo-controlled food challenge (DBPCFC) and maximum tolerated dose (mg of protein) between rush and conventional protocol subjects at the end of the study (7 months of treatment)

Time frame
End of study (7 months of treatment)
4

Comparison of the median number of days needed in both groups, rush vs conventional, to complete the Induction Phase (Part 1) in subjects accomplishing this outcome

Time frame
Throughout the Induction Phase (Part 1), 1 week up to 7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pablo Rodríguez del Rio

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Sponsor institution

Source ClinicalTrials.gov
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