A phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover, single-dose clinical trial of a new class of bronchodilator for acute asthma

• DOI: 10.1186/s13063-018-2720-6
• Publication Date: 2018-06-18T07:31:43Z
• Authors: Veronica Swystun; Francis H. Y. Green; John H. Dennis; Emmanouil Rampakakis; Gurkeet Lalli; Morenike Fadayomi; Andrea Chiu; Grishma Shrestha; Sharif Galal El S...; David Evan Nelson; Tamer Y. El Mays; Cora A. Pieron; Richard Leigh
• Keywords: Tolerability; Crossover study; Bronchodilator Agents

This study evaluates a novel bronchodilator, S1226, for its efficacy in reversing allergen-induced bronchoconstriction subjects with mild, allergic asthma. S1226 is new class of bronchodilator that an aerosol/vapor/gas mixture combining pharmacological and biophysical principles mode action. It contains potent gas (carbon dioxide or CO2) nebulized perflubron (a synthetic surfactant possessing mucolytic properties). has demonstrated rapid reversal ovine model. was phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover single-dose clinical trial to evaluate the safety, tolerability, (8% administered by nebulization following early asthmatic response 12 Primary safety endpoints were adverse events, vital signs, pulse oximetry, spirometry. Efficacy included (measured as forced expiratory volume 1 s FEV1) over time, area under curve FEV1 achievement responder status, defined 12% improvement after allergen challenge. No significant issues observed. All events non-serious, transient. There statistically decrease peripheral blood oxygenation levels time placebo group inhalation, whereas maintained at normal S1226-treated (P = 0.028). effect greatest 5 min start treatment < 0.001). The recovery rate faster but not significantly so 0.272) compared earlier points (5, 10, 15 min), assessed ≥12% FEV1. greater 0.04) placebo. safe, tolerated well, provided bronchodilation improved mild atopic asthma bronchoconstriction. Additional studies optimize therapeutic are indicated. ClinicalTrials.gov, NCT02334553 . Registered on November 2014.