rescue medication use

Secondary endpoint: Daily rescue albuterol use reduced by nearly one-third compared with placebo over 24 weeks^1-4

All treatments were administered BID.

BEVESPI AEROSPHERE (glycopyrrolate/formoterol fumarate) is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
In Trial 1, mean change from baseline in daily rescue albuterol use was -0.8 puffs/day (baseline 3.2 puffs/day) over 24 weeks with BEVESPI AEROSPHERE (n=525), compared with an increase of 0.3 puffs/day with placebo (n=218) (P<0.0001)^1-3†
Statistically significant reduction in average daily rescue medication use vs placebo was also demonstrated in Trial 2^1,2,4‡
Adverse reactions with BEVESPI AEROSPHERE with a ≥2% incidence and more common than placebo were urinary tract infection and cough¹

^*P value is based on treatment comparison of absolute mean change from baseline for BEVESPI AEROSPHERE vs placebo.

^†In Trial 1, mean change from baseline in daily rescue albuterol use over 24 weeks was -0.5 puffs/day (baseline 3.4 puffs/day) with glycopyrrolate 18 mcg (n=449), -0.8 puffs/day (baseline 3.4 puffs/day) with formoterol fumarate 9.6 mcg (n=446), and 0.3 puffs/day (baseline 3.4 puffs/day) with placebo (n=218) (P<0.0001 for all active treatments vs placebo).

^‡Trial 2 demonstrated a 31% reduction from baseline in rescue albuterol use vs placebo (P<0.0001). P value is based on treatment comparison of absolute mean change from baseline for BEVESPI AEROSPHERE vs placebo. In Trial 2, mean change from baseline in daily rescue albuterol use was -1.0 puffs/day over 24 weeks with BEVESPI AEROSPHERE (baseline 3.2 puffs/day, n=510), -0.4 puffs/day with glycopyrrolate 18 mcg (baseline 3.6 puffs/day, n=438), -0.7 puffs/day with formoterol fumarate 9.6 mcg (baseline 3.5 puffs/day, n=437), and 0.0 puffs/day with placebo (baseline 3.9 puffs/day, n=223) (P<0.01 for all active treatments vs placebo).

Please see Important Safety Information and full Prescribing Information, including Boxed WARNING available on website.

References: 1. BEVESPI AEROSPHERE [Package Insert]. Wilmington, DE: AstraZeneca; 2017. 2. Martinez FJ, Rabe KF, Ferguson GT, et al. Chest. 2017;151(2):340-357. 3. Data on File, REF-5037, AZPLP. 4. Data on File, REF-5036, AZPLP.