Clinical trial NCT05653024: INhaled Salbutamol vs Placebo for the Treatment of Acute IgE-mediated Abdominal Pain From Allergic Food REactions
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: IgE-mediated Abdominal Pain
Keywords: food allergy
anaphylaxis
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to resolution of moderate-to-severe abdominal pain
timeFrame: 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:
measure: Time to complete resolution of the abdominal pain
timeFrame: From time of administation of investigational product, until the pain is completely resolved, assessed up to 30 minutes
measure: Time to any improvement in the abdominal pain
timeFrame: From time of administation of investigational product, until any decrease in the NRS-11, assessed up to 30 minutes
measure: Epinephrine use
timeFrame: From randomization to three days after randomization
measure: Adverse events
timeFrame: From randomization to three days after randomization
Other outcomes:
measure: Time to resolution of moderate-to-severe abdominal pain after open-label rescue
timeFrame: 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
measure: Time to resolution of abdominal pain after open-label rescue
timeFrame: From time of administation of open-label rescue treatment, until complete resolution of the abdominal pain, assessed up to patient discharge
measure: Time to any improvement in abdominal pain after open-label rescue
timeFrame: From time of administation of open-label rescue treatment, until any decrease in the NRS-11, assessed up to patient discharge
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Philippe Bégin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: