Background: Symptoms of
chronic obstructive pulmonary disease (
COPD) may diminish patients' health-related quality of life (HRQoL). We report effects of Longhala™ Magnair™ (
glycopyrrolate) Inhalation
Solution, a
drug/device combination of the long-acting
antimuscarinic glycopyrrolate administered using the eFlow® closed system (eFlow CS)
nebulizer, on HRQoL from the
Glycopyrrolate for
Obstructive Lung Disease Via Electronic
Nebulizer (GOLDEN) clinical studies. Methods: Data consisted of a pooled analysis of 2 phase 3, 12-week efficacy studies (GOLDEN-3 and -4) of
glycopyrrolate/eFlow CS (25 or 50 mcg twice daily [BID]) versus placebo, and a 48-week, open-label safety study (GOLDEN-5) of
glycopyrrolate/eFlow CS 50 mcg BID versus
tiotropium 18 mcg once daily in patients with moderate to very severe
COPD. Change from baseline in HRQoL was measured via the St George's Respiratory Questionnaire (SGRQ). Results are provided as mean changes in SGRQ Total score and as response analysis (≥4-point improvement [responder], no change, and ≥4-point worsening in Total score) using analysis of covariance or logistic regression, as applicable. Results: Atotal of 1293 patients were evaluated from GOLDEN-3 and -4 and 1086 from GOLDEN-5.
Glycopyrrolate/eFlow CS significantly improved SGRQ Total and component scores. The percentage of SGRQ responders in pooled GOLDEN-3/4 was 46.8% for
glycopyrrolate/eFlow CS 25 mcg, 41.7% for
glycopyrrolate/eFlow CS 50 mcg, and 34.5% for placebo. SGRQ Total and component score improvements were similar between
glycopyrrolate/eFlow CS and
tiotropium in GOLDEN-5. Conclusions: The
drug/device combination of
glycopyrrolate/eFlow CS significantly improved HRQoL, as measured by the SGRQ, offering a potential maintenance treatment option in patients with moderate to very severe
COPD. ClinicalTrials.gov: NCT02347761, NCT02347774, NCT02276222.