INhaled Salbutamol vs Placebo for the Treatment of Acute IgE-mediated Abdominal Pain From Allergic Food REactions

• Status: Not yet recruiting
• Trial end date: 2025-07-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philippe Bégin
• Treatments: Albuterol

Criteria

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.