Study was stopped due to unforseen changes in clinical practice (new oral immunotherapy focus on infants and toddlers) which led to a decrease in eligible participants and failure to meet recruitement targets.

The goal of this study is to assess the efficacy of inhaled salbutamol to treat abdominal pain during food allergic reactions.

Patients experiencing abominal pain as a result of a food allergic reaction during a food challenge in the allergy clinic will be invited to participate to the study.

They will receive either 8 puffs of salbutamol (asthma inhaler) or 8 puffs of a placebo inhaler.

The abdominal pain will then be followed using a numeric scale to see if patients receiving the medication experienced a faster improvement compared to those receiving the placebo.

This trial aims to compare the efficacy of inhaled salbutamol compared to placebo to decrease the duration of abdominal pain in children and adults with IgE-mediated food allergic reactions.

The population will be children and adults aged 6 to 55 presenting with moderate to severe IgE-mediated abdominal pain in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.

Eligible participants will be randomized to receive an immediate treatement with either inhaled salbutamol 800 mcg or inhaled placebo, dispensed with a spacer, at a ratio of 1:1.

Participants will be asked to rate the evolution of their abdominal pain by the minute on the NRS-11 scale until it resolves completely or that they have been discharged.

Patients still presenting moderate to severe abdominal pain 30 minutes after the administration of the investigational product will receive an open-label treatment with 800 mcg of inhaled salbutamol.

The primary outcome is the time from treatment to a decrease of the abdominal pain down to a mild intensity (defined as a pain for which the patient would not normally seek treatment).

Participants will be contacted by phone after three days to document any adverse event.

The primary endpoint will be analysed using a log-rank test.

Inclusion Criteria:

• Subjects aged between 6 to 55 years old.
• Undergoing an oral food challenge or an oral immunotherapy up-dosing visit for the diagnosis or treatment of an IgE-mediated food allergy.
• Previous confirmation of the food allergy by either skin prick tests (SPT) or serum specific IgE;
• Able to express the intensity of their pain using the NRS-11;
• Willing to comply with all study requirements.

Exclusion Criteria:

• Previous adverse reactions to salbutamol;
• Known hypersensitivity to salbutamol or placebo or any of their components;
• Any condition that could be considered a relative contra-indication to the use of salbutamol according to the investigator (e.g. patient with a history of hyperglycemia, arrhythmia or hypokalemia);
• Patients receiving beta-blockers or a daily / long-acting beta agonists;
• Patients needing to pass an anti-doping test for high-level sport in the following 24h.

Available upon request to corresponding author

Protocol and SAP will be provided as supplementary material at time of study publication.

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