Nebulized revefenacin improves health status of patients with moderate to very severe COPD: Study

Chronic obstructive pulmonary disease (COPD) is a leading cause of death and disability, investigation is essential for better management in both men and women. 

A randomized trial by Gary Ferguson and team revealed that nebulized revefenacin produced significant improvements in COPD Assessment Test (CAT) scores in women and men with moderate to very severe COPD, they also revealed significant improvements in St George's Respiratory Questionnaire (SGRQ) scores in women alone when compared with placebo. Maintenance treatment with revefenacin can improve health status of patients with moderate to very severe COPD; however, the effect may be more pronounced in women than men.

The findings of the study are published in Chest Journal.

The objective of the study was to evaluate the efficacy of nebulized revefenacin in women and men with moderate to very severe COPD treated with revefenacin conducted in phase 3 trials.

The study was a placebo-controlled trials (NCT02459080 and NCT02512510), Efficacy data was taken from two 12-week and safety data were pooled from the 12-week trials and a 52-week tiotropium-controlled safety trial (NCT02518139). Participants received revefenacin 175 µg via a standard jet nebulizer or placebo in the 12-week or tiotropium in the 52-week study. Patient-reported outcomes included change from baseline in SGRQ and CAT scores on day 85 and responder analysis, including participants with ≥4-unit decrease from baseline in SGRQ and ≥2-unit decrease in CAT scores.

The results of the study were

• A total of 812 participants from the 12-week studies included in the intent-to-treat analysis, 411 (51%) were women. Average age was 63 years for women and 64 years for men.

• Revefenacin produced significant improvements from baseline in SGRQ scores with placebo-adjusted least squares (LS) in women; the difference was not significant for men.

• Clinically relevant improvements in SGRQ occurred in 53% of women for revefenacin/placebo,) and 41% of men on revefenacin.

• Significant improvements were observed in the CAT scores of women (placebo-adjusted LS mean [95% CI], −2.3 [−3.4 to −1.2]; P<0.0001) and men (−1.2 [−2.3 to −0.1]; P=0.04) treated with revefenacin.

• Clinically relevant improvements in CAT were reported in 51% of women and 47% of men on revefenacin.

• Incidence of adverse events (AEs) was similar between women (63%) and men (59%). There were minimal reports of antimuscarinic effect–related AEs (women, 2%; men, 1%).

Ferguson and team concluded that "Compared with placebo, nebulized revefenacin produced significant improvements in CAT scores in women and men with moderate to very severe COPD, and significant improvements in SGRQ scores in women alone. Overall, AEs were minimal and similar in women and men."

Reference:

https://doi.org/10.1016/j.chest.2021.07.1617