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

NCT05653024 | Terminated Phase 3 DMC

• 1 other identifier: CITO-2022-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

IgE-mediated Abdominal Pain

Keywords

food allergy; anaphylaxis

Outcome Measures

Primary Outcomes (1)

• Time to resolution of moderate-to-severe abdominal pain

  Time from treatment to an abdominal pain of less than moderate intensity, defined as a pain for which the patient would not normally seek treatment

  From time of administation of investigational product, until the pain decreases to a point where the patient would not normally seek treatment, assessed up to 30 minutes

Secondary Outcomes (4)

• Time to complete resolution of the abdominal pain

  From time of administation of investigational product, until the pain is completely resolved, assessed up to 30 minutes

• Time to any improvement in the abdominal pain

  From time of administation of investigational product, until any decrease in the NRS-11, assessed up to 30 minutes

• Epinephrine use

  From randomization to three days after randomization

• Adverse events

  From randomization to three days after randomization

Other Outcomes (3)

• Time to resolution of moderate-to-severe abdominal pain after open-label rescue

  From time of administation of open-label rescue treatment, until the pain decreases to a point where the patient would not normally seek treatment, assessed up to patient discharge

• Time to resolution of abdominal pain after open-label rescue

  From time of administation of open-label rescue treatment, until complete resolution of the abdominal pain, assessed up to patient discharge

• Time to any improvement in abdominal pain after open-label rescue

  From time of administation of open-label rescue treatment, until any decrease in the NRS-11, assessed up to patient discharge

Study Arms (2)

Inhaled salbutamol

EXPERIMENTAL

8 puffs of 100 mcg of inhaled salbutamol once

Drug: Salbutamol

Placebo

PLACEBO COMPARATOR

8 puffs of inhaled placebo once

Drug: Placebo

Interventions

Salbutamol DRUG

8 puffs of 100 mcg inhaled salbutamol administered with spacer

Also known as: Albuterol

Inhaled salbutamol

Placebo DRUG

8 puffs of placebo inhaler administered with spacer

Placebo

Eligibility Criteria

• Age: 6 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philippe Bégin: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Food Hypersensitivity; Anaphylaxis

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Philippe Bégin, MD PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 15, 2022
• Study Start: July 1, 2023
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Protocol and SAP will be provided as supplementary material at time of study publication.
• Access Criteria: As per journal policy

Locations

CA (1)