A Double-blind Randomized Controlled Trial of Inhaled Salbutamol vs Placebo for the Treatment of Acute Abdominal Pain From Food-induced IgE-mediated Reactions

Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 55
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Canada
CHU Sainte-Justine
Montreal
Time Frame
Start Date: 2023-07-01
Completion Date: 2025-05-05
Participants
Target number of participants: 24
Treatments
Experimental: Inhaled salbutamol
8 puffs of 100 mcg of inhaled salbutamol once
Placebo_comparator: Placebo
8 puffs of inhaled placebo once
Related Therapeutic Areas
Sponsors
Leads: Philippe Bégin

This content was sourced from clinicaltrials.gov