Inhaled Salbutamol Versus Placebo for the Treatment of Acute IgE-Mediated Abdominal Pain From Allergic Food Reactions (INSPIRE Trial): A Double-Blind Randomized Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical 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.
Authors: Camille Braun, Eloïse Antony, Marie-Lee Simard, Kathryn Samaan, François Graham, Florence Gingras-Lessard, Roxane Labrosse, Louis Paradis, Anne Des Roches, Philippe Bégin, Samina Ali, Waleed Alqurashi, Aikaterini Anagnostou, Stefania Arasi, Moshe Ben-Shoshan, Marie-Josée Bettez, R. Sharon Chinthrajah, Raoul Daoust, Abigail Davis, Thomas Eiwegger, Mohamed Eltorki, David Fleischer, Edwin Kim, Jocelyn Gravel, Jennifer Gerdts, Matthew Greenhawt, Guillaume Lezmi, Douglas P. Mack, Thomas G. Poder, Paul Turner, Julia Upton, Matthieu Vincent
Language: English
Subfield: Immunology and Allergy
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,000
OpenAlex ID: W7164919967