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NCT05653024
INhaled Salbutamol vs Placebo for the Treatment of Acute IgE-mediated Abdominal Pain From Allergic Food REactions
Conditions: IgE-mediated Abdominal Pain
Sex: All
Ages: 6 Years – 55 Years
Phase: PHASE3
Enrollment: 498
Sponsor: Philippe Bégin
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT05653024). StuddyBuddy aggregates publicly available trial information.