Inhaled Salbutamol Versus Placebo for the Treatment of Acute IgE-Mediated Abdominal Pain From Allergic Food Reactions (INSPIRE Trial): A Double-Blind Randomized Trial
Abstract
BACKGROUND: -adrenergic agonist, may induce relaxation of gastrointestinal smooth muscle. OBJECTIVE: To evaluate the efficacy of inhaled salbutamol versus placebo for the treatment of moderate-to-severe IgE-mediated abdominal pain reactions. METHODS: This randomized, double-blind, placebo-controlled trial enrolled patients aged 6 years to 55 years or less who developed moderate-to-severe abdominal pain during an oral food challenge or oral immunotherapy dose administration. Participants were randomized (1:1) to receive 800 μg of inhaled salbutamol or placebo. Participants self-reported pain intensity at 1-minute intervals for 30 minutes using the Numerical Rating Scale. The primary outcome was time to patient-perceived adequate analgesia. RESULTS: Twenty-four participants (median age, 11.5 years, 37.5% females) were randomized at a single center. The median time to patient-perceived adequate analgesia was 6.0 minutes in the salbutamol group and was not reached by 30 minutes in the placebo group (hazard ratio, 0.35; 95% CI, 0.12-0.99; P = .034). The median time to complete resolution of abdominal pain was 10.0 minutes with salbutamol and was not reached by 30 minutes in the placebo group (hazard ratio, 0.33; 95% CI, 0.12-0.92; P = .027). The trial was terminated early because of changes in clinical practice resulting in slower-than-expected recruitment. CONCLUSIONS: In this prematurely terminated randomized trial, inhaled salbutamol was associated with faster relief from IgE-mediated, food allergy-related abdominal pain compared with placebo. These findings require confirmation in a larger, multicenter study.
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BibTeX
@article{braun2026inhaled,
title = {{Inhaled Salbutamol Versus Placebo for the Treatment of Acute IgE-Mediated Abdominal Pain From Allergic Food Reactions (INSPIRE Trial): A Double-Blind Randomized Trial}},
author = {Camille Braun and Eloïse Antony and Marie-Lee Simard and Kathryn Samaan and François Graham and Florence Gingras-Lessard and Roxane Labrosse and Louis Paradis and Anne Des Roches and Philippe Bégin and Samina Ali and Waleed Alqurashi and Aikaterini Anagnostou and Stefania Arasi and Moshe Ben-Shoshan and Marie-Josée Bettez and R. Sharon Chinthrajah and Raoul Daoust and Abigail Davis and Thomas Eiwegger and Mohamed Eltorki and David Fleischer and Edwin Kim and Jocelyn Gravel and Jennifer Gerdts and Matthew Greenhawt and Guillaume Lezmi and Douglas Mack and Thomas Poder and Paul Turner and Julia Upton and Matthieu Vincent},
journal = {Journal of Allergy and Clinical Immunology: In Practice},
year = {2026},
month = oct,
doi = {10.1016/j.jaip.2026.05.036},
url = {https://hal.science/hal-05795488v1},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Inhaled Salbutamol Versus Placebo for the Treatment of Acute IgE-Mediated Abdominal Pain From Allergic Food Reactions (INSPIRE Trial): A Double-Blind Randomized Trial
AU - Camille Braun
AU - Eloïse Antony
AU - Marie-Lee Simard
AU - Kathryn Samaan
AU - François Graham
AU - Florence Gingras-Lessard
AU - Roxane Labrosse
AU - Louis Paradis
AU - Anne Des Roches
AU - Philippe Bégin
AU - Samina Ali
AU - Waleed Alqurashi
AU - Aikaterini Anagnostou
AU - Stefania Arasi
AU - Moshe Ben-Shoshan
AU - Marie-Josée Bettez
AU - R. Sharon Chinthrajah
AU - Raoul Daoust
AU - Abigail Davis
AU - Thomas Eiwegger
AU - Mohamed Eltorki
AU - David Fleischer
AU - Edwin Kim
AU - Jocelyn Gravel
AU - Jennifer Gerdts
AU - Matthew Greenhawt
AU - Guillaume Lezmi
AU - Douglas Mack
AU - Thomas Poder
AU - Paul Turner
AU - Julia Upton
AU - Matthieu Vincent
PY - 2026
DA - 2026/10/12
JO - Journal of Allergy and Clinical Immunology: In Practice
DO - 10.1016/j.jaip.2026.05.036
UR - https://hal.science/hal-05795488v1
AB - BACKGROUND: -adrenergic agonist, may induce relaxation of gastrointestinal smooth muscle. OBJECTIVE: To evaluate the efficacy of inhaled salbutamol versus placebo for the treatment of moderate-to-severe IgE-mediated abdominal pain reactions. METHODS: This randomized, double-blind, placebo-controlled trial enrolled patients aged 6 years to 55 years or less who developed moderate-to-severe abdominal pain during an oral food challenge or oral immunotherapy dose administration. Participants were randomized (1:1) to receive 800 μg of inhaled salbutamol or placebo. Participants self-reported pain intensity at 1-minute intervals for 30 minutes using the Numerical Rating Scale. The primary outcome was time to patient-perceived adequate analgesia. RESULTS: Twenty-four participants (median age, 11.5 years, 37.5% females) were randomized at a single center. The median time to patient-perceived adequate analgesia was 6.0 minutes in the salbutamol group and was not reached by 30 minutes in the placebo group (hazard ratio, 0.35; 95% CI, 0.12-0.99; P = .034). The median time to complete resolution of abdominal pain was 10.0 minutes with salbutamol and was not reached by 30 minutes in the placebo group (hazard ratio, 0.33; 95% CI, 0.12-0.92; P = .027). The trial was terminated early because of changes in clinical practice resulting in slower-than-expected recruitment. CONCLUSIONS: In this prematurely terminated randomized trial, inhaled salbutamol was associated with faster relief from IgE-mediated, food allergy-related abdominal pain compared with placebo. These findings require confirmation in a larger, multicenter study.
SN - 2213-2198
SN - 2213-2201
ER -