Once-daily revefenacin when administered via a jet nebulizer with formoterol was well tolerated and associated with greater lung function response compared with formoterol alone in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), according to research presented at the 2020 CHEST Annual Meeting held virtually, October 18-21.
In a phase 3 study (ClinicalTrials.gov Identifier: NCT03573817), a total of 122 patients with COPD were randomly assigned to either revefenacin (n=63) or placebo (n=59). Treatment with revefenacin and placebo was followed by formoterol administered in the morning and the evening for 21 days via a standard jet nebulizer. Patients received their assigned treatment regimen for an additional 21 days. For morning treatments, revefenacin or placebo with formoterol were administered together in a single nebulization, whereas formoterol monotherapy was administered in the evening.
During and after treatment, the investigators assessed for adverse events (AEs), serious AEs (SAEs), discontinuations, deaths, and trough forced expiratory volume in 1 second (FEV1) changes compared with baseline. These outcomes were assessed in patients stratified by smoking status, age, current inhaled corticosteroids (ICS) use, reversibility to a short-acting bronchodilator (ipratropium), and 2017 Global Initiative for Chronic Obstructive Lung Disease grades 3 and 4.
The mean age of the overall patient population was 64 years. Approximately 57% of patients were smokers, and 24% were taking ICS. Overall, the trough FEV1response was greater in patients who received revefenacin and formoterol (sequential range, 66.0-253.5 mL; combined range, 63.1-170.5 mL) compared with formoterol monotherapy (sequential range, -37.3 to116.6 mL; combined range, -19.5 to86.2 mL). In addition, the least squares mean differences in FEV1 were smaller in patients who were not reversible to ipratropium and those who were former smokers compared with other subgroups.
The proportion of AEs ranged between 0% and 20%. The most common AEs across all subgroups were exacerbation/worsening of COPD, cough, and dizziness. Most of the AEs were reported in the placebo group. There were no discontinuations related to AEs in the revefenacin subgroups. Additionally, there were no SAEs or deaths during the study.
Based on these findings, the investigators suggest that “sequential or combined delivery of a long-acting muscarinic antagonist (LAMA) and long-acting b-agonist (LABA) via a standard jet nebulizer could be a treatment option for patients with COPD.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Siler T, Moran E, Barnes C, Crater G. Tolerability, safety, and lung function response of revefenacin and formoterol via nebulization in patients with moderate to very severe COPD: a subgroup analysis of a phase 3 trial. Presented at: CHEST Virtual Annual Meeting; October 18-21, 2020. Abstract 1749.
This article originally appeared on Pulmonology Advisor