|The following article is part of conference coverage from the CHEST 2017 in Toronto, Canada. Visit Pulmonology Advisor’s conference page for more conference news.|
TORONTO — The use of nebulized glycopyrrolate (GLY) with concurrent bronchodilators is tolerable, safe, and effective for improving lung function in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), according to findings from a phase 3 study presented at CHEST 2017, held October 28 to November 1 in Toronto, Ontario, Canada.
In this study, researchers combined data from 2 placebo-controlled trials and 1 active-controlled study, pooling together a total of 2379 patients who had background beta 2-agonist (LABA) use ± inhaled corticosteroids (ICS; n=861) or no background LABA ± ICS (n=1518). All patients were randomly assigned to receive either 25 or 50 μg GLY twice daily, delivered via an investigational closed system nebulizer (eFlow Closed System, PARI Pharma); 18 μg tiotropium once daily; or placebo.
Compared with placebo, patients with background LABA taking GLY at either dose experienced significant improvements in trough forced expiratory volume at 1 second (92-110 mL; P <.001) at 12 weeks. In addition, GLY was associated with greater improvements in St. George’s Respiratory Questionnaire scores in LABA (−2.073 to −3.888 vs placebo; P <.05).
Rates of COPD exacerbations were similar across all treatment groups. Compared with placebo at week 12, the rates of adverse events causing discontinuation of therapy were lower in the patients taking GLY.
Contrary to these data, higher discontinuation rates were observed in the GLY LABA subgroups compared with tiotropium. Two major adverse cardiac events occurred in the no-LABA placebo patient group vs 3 in the no-LABA 50 μg GLY group.
“Nebulized GLY is well tolerated and effective when administered with or without concurrent bronchodilator therapy and provides a novel treatment option for patients who may require or benefit from nebulized LABA therapy,” the investigators concluded.
Kerwin EM, Tosiello R, Price B, Goodin T. The effect of concurrent bronchodilator therapy on the efficacy and safety of a novel, nebulized glycopyrrolate in phase 3 studies in subjects with moderate to very severe COPD. Presented at: CHEST 2017; October 28-November 1, 2017; Toronto, Ontario, Canada. Abstract 2743310.