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Safety and Efficacy of Revefenacin and Formoterol in Sequence and Combination via a Standard Jet Nebulizer in Patients with Chronic Obstructive Pulmonary Disease: A Phase 3b, Randomized, 42-Day Study. | LitMetric

AI Article Synopsis

  • A study explored the safety and effectiveness of the dual delivery of revefenacin (a long-acting muscarinic antagonist) and formoterol (a long-acting beta2-agonist) for treating chronic obstructive pulmonary disease (COPD) using a standard jet nebulizer.
  • The trial involved 122 patients and compared the effects of sequential and combined nebulization methods, with results showing fewer adverse events in patients receiving revefenacin compared to placebo.
  • Revefenacin, when administered alongside formoterol, led to greater improvements in lung function (measured as forced expiratory volume) than formoterol alone, with no serious adverse events reported.

Article Abstract

Although no nebulized, dual mechanism, long-acting bronchodilator is currently marketed, with the approval of once-daily long-acting muscarinic antagonist (LAMA) revefenacinefenacin, it is theoretically possible to deliver a LAMA and long-acting beta2-agonist via standard jet nebulizer. The primary and secondary objectives of our study were to characterize the safety profile of revefenacin administered sequentially before or in combination with formoterol, via standard jet nebulizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). In this randomized, double-blind, 42-day trial (NCT03573817), patients received revenacin 175 µg (n=63) or placebo (n=59), followed by formoterol 20 µg in the morning and formoterol alone in the evening formoterol 21 days via standard jet nebulizer (sequential administration). For another 21 days, revefenacin/placebo and formoterol, were administered as mixed solutions via single nebulization in the morning (combined administration), and formoterol alone in the evening. The adverse events' (AEs) incidence was higher in the placebo + formoterol arms (11%-12%) than in the revefenacin + formoterol arms (5%-8%). The most common AEs were worsening/exacerbation of COPD, cough, and dizziness. There were no serious AEs or deaths reported in any arm. The least squares mean in trough forced expiratory volume in 1 second (FEV) versus baseline was higher in the revefenacin + formoterol arms (116-157 mL) than in the placebo + formoterol arms (35-53 mL). Revefenacin had a safety profile similar to formoterol alone when delivered sequentially or combined. Trough FEV was similar when revefenacin was delivered sequentially or combined with formoterol, with revefenacin providing an additional 81-104 mL improvements over formoterol alone.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454021PMC
http://dx.doi.org/10.15326/jcopdf.7.2.2019.0154DOI Listing

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