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

Primary Purpose

IgE-mediated Abdominal Pain

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Salbutamol
Placebo
Sponsored by
Philippe Bégin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgE-mediated Abdominal Pain focused on measuring food allergy, anaphylaxis

Eligibility Criteria

6 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Inhaled salbutamol

    Placebo

    Arm Description

    8 puffs of 100 mcg of inhaled salbutamol once

    8 puffs of inhaled placebo once

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Time to complete resolution of the abdominal pain
    Time from treatment to the complete resolution of the abdominal pain.
    Time to any improvement in the abdominal pain
    Time from treatment to any decrease in the 11-point numeric pain rating scale (NRS-11)
    Epinephrine use
    Overall rate of epinephrine administration following randomization
    Adverse events
    Overall rate of adverse events following randomization

    Full Information

    First Posted
    November 22, 2022
    Last Updated
    April 11, 2023
    Sponsor
    Philippe Bégin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05653024
    Brief Title
    INhaled Salbutamol vs Placebo for the Treatment of Acute IgE-mediated Abdominal Pain From Allergic Food REactions
    Acronym
    INSPIRE
    Official Title
    A Double-blind Randomized Controlled Trial of Inhaled Salbutamol vs Placebo for the Treatment of Acute Abdominal Pain From Food-induced IgE-mediated Reactions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2023 (Anticipated)
    Primary Completion Date
    December 25, 2024 (Anticipated)
    Study Completion Date
    July 27, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Philippe Bégin

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    IgE-mediated Abdominal Pain
    Keywords
    food allergy, anaphylaxis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    498 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Inhaled salbutamol
    Arm Type
    Experimental
    Arm Description
    8 puffs of 100 mcg of inhaled salbutamol once
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    8 puffs of inhaled placebo once
    Intervention Type
    Drug
    Intervention Name(s)
    Salbutamol
    Intervention Description
    8 puffs of 100 mcg inhaled salbutamol administered with spacer
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    8 puffs of placebo inhaler administered with spacer
    Primary Outcome Measure Information:
    Title
    Time to resolution of moderate-to-severe abdominal pain
    Description
    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
    Time Frame
    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 Measure Information:
    Title
    Time to complete resolution of the abdominal pain
    Description
    Time from treatment to the complete resolution of the abdominal pain.
    Time Frame
    From time of administation of investigational product, until the pain is completely resolved, assessed up to 30 minutes
    Title
    Time to any improvement in the abdominal pain
    Description
    Time from treatment to any decrease in the 11-point numeric pain rating scale (NRS-11)
    Time Frame
    From time of administation of investigational product, until any decrease in the NRS-11, assessed up to 30 minutes
    Title
    Epinephrine use
    Description
    Overall rate of epinephrine administration following randomization
    Time Frame
    From randomization to three days after randomization
    Title
    Adverse events
    Description
    Overall rate of adverse events following randomization
    Time Frame
    From randomization to three days after randomization
    Other Pre-specified Outcome Measures:
    Title
    Time to resolution of moderate-to-severe abdominal pain after open-label rescue
    Description
    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
    Time Frame
    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
    Title
    Time to resolution of abdominal pain after open-label rescue
    Description
    Time from open-label rescue treatment to complete resolution of abdominal pain
    Time Frame
    From time of administation of open-label rescue treatment, until complete resolution of the abdominal pain, assessed up to patient discharge
    Title
    Time to any improvement in abdominal pain after open-label rescue
    Description
    Time from open-label rescue treatment to any decrease in the NRS-11
    Time Frame
    From time of administation of open-label rescue treatment, until any decrease in the NRS-11, assessed up to patient discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

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

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