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

Study Overview
=================
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.

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

Conditions
-----------------
IgE-mediated Abdominal Pain

Intervention / Treatment
-----------------
* Drug: Salbutamol
* Drug: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled salbutamol<br>8 puffs of 100 mcg of inhaled salbutamol once | Drug: Salbutamol<br>* 8 puffs of 100 mcg inhaled salbutamol administered with spacer<br>|
| Placebo Comparator: Placebo<br>8 puffs of inhaled placebo once | Drug: Placebo<br>* 8 puffs of placebo inhaler administered with spacer<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food allergy, anaphylaxis