drugset / Trial / NCT04503460

Mechanisms of Adverse Effects of Long-Acting Beta-Agonists in Asthma

NCT04503460

NaSequentialOpen-labelBasic science

Summary

This study aims to elucidate the pathophysiological mechanisms underlying the adverse effects associated with the use of long-acting beta-agonists (LABAs) in asthma. Participants with mild asthma will be enrolled into a single-arm, unblinded trial in which they receive 2 weeks of salmeterol xinafoate monotherapy, followed by a 2-week washout period, followed by 2 weeks of salmeterol xinafoate / fluticasone propionate combination therapy. The induction of asthma disease-relevant pro-inflammatory mediators in the airways will be measured at each stage and correlated with relevant clinical parameters.

Timeline

Start
2021-07-23
Primary completion
2024-09-30
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone Other / unclassified 250 ug Inhaled
Subject Salmeterol Other / unclassified 50 ug Inhaled

Indications