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

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

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.

Study Overview

• Status: Terminated
• Conditions: IgE-mediated Abdominal Pain
• Intervention / Treatment: Drug: Salbutamol; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 51 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhaled salbutamol; 8 puffs of 100 mcg of inhaled salbutamol once	Drug: Salbutamol; 8 puffs of 100 mcg inhaled salbutamol administered with spacer; Other Names: Albuterol
Placebo Comparator: Placebo; 8 puffs of inhaled placebo once	Drug: Placebo; 8 puffs of placebo inhaler administered with spacer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete resolution of the abdominal pain	Time from treatment to the 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	Time from treatment to any decrease in the 11-point numeric pain rating scale (NRS-11)	From time of administation of investigational product, until any decrease in the NRS-11, assessed up to 30 minutes
Epinephrine use	Overall rate of epinephrine administration following randomization	From randomization to three days after randomization
Adverse events	Overall rate of adverse events following randomization	From randomization to three days after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resolution of moderate-to-severe abdominal pain after open-label rescue	Time from open-label rescue 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 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 any improvement in abdominal pain after open-label rescue	Time from open-label rescue treatment to any decrease in the NRS-11	From time of administation of open-label rescue treatment, until any decrease in the NRS-11, assessed up to patient discharge
Time to resolution of abdominal pain after open-label rescue	Time from open-label rescue treatment to complete resolution of abdominal pain	From time of administation of open-label rescue treatment, until complete resolution of the abdominal pain, assessed up to patient discharge

Collaborators and Investigators

• Sponsor: Philippe Bégin
• Investigators: Principal Investigator: Philippe Bégin, MD PhD, St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): May 5, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: food allergy; anaphylaxis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Reproductive Control Agents; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: CITO-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available upon request to corresponding author
• IPD Sharing Time Frame: Protocol and SAP will be provided as supplementary material at time of study publication.
• IPD Sharing Access Criteria: As per journal policy
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No