INhaled Salbutamol vs Placebo for the Treatment of Acute IgE-mediated Abdominal Pain From Allergic Food REactions (INSPIRE)
IgE-mediated Abdominal Pain
About this trial
This is an interventional treatment trial for IgE-mediated Abdominal Pain focused on measuring food allergy, anaphylaxis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Inhaled salbutamol
Placebo
8 puffs of 100 mcg of inhaled salbutamol once
8 puffs of inhaled placebo once