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

NCT ID: NCT05653024

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-05-05

Brief 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.

Detailed Description

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.

Conditions

IgE-mediated Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Inhaled salbutamol

8 puffs of 100 mcg of inhaled salbutamol once

Group Type: EXPERIMENTAL

Salbutamol

Intervention Type: DRUG

8 puffs of 100 mcg inhaled salbutamol administered with spacer

Placebo

8 puffs of inhaled placebo once

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

8 puffs of placebo inhaler administered with spacer

Interventions

Salbutamol

8 puffs of 100 mcg inhaled salbutamol administered with spacer

Intervention Type: DRUG

Placebo

8 puffs of placebo inhaler administered with spacer

Intervention Type: DRUG

Other Intervention Names

Albuterol

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philippe Bégin

OTHER

Sponsor Role: lead

Responsible Party

Philippe Bégin

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Philippe Bégin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CITO-2022-01

Identifier Type: -

Identifier Source: org_study_id