MAXIMIZE
BRONCHODILATION...1,2*

 

Primary endpoint: 150-mL increase from baseline in predose FEV1 at Week 24 vs placebo (P<0.0001) in Trial 11,2†

BEVESPI AEROSPHERE is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

*Improvements in lung function, including predose FEV1 and peak FEV1 , relative to its individual components and placebo in two 24-week pivotal trials



Primary endpoint: Change from baseline in morning predose FEV1 at Week 241,2

Secondary endpoint: Mean change from baseline in peak FEV1 within 2 hours post-dose at Week 241,2

Secondary endpoint: Time to onset of action on Day 11,2

In separate Phase IIIb Trials: Through the breathing cycle3,4

Chart showing 150 mL increase in predose FEV1 vs placebo at Week 24 Graph displaying the mean change from baseline in peak FEV1 within 2 hours post-dose at Week 24 FEV at 5 mins vs placebo
 
 
 
Chart showing 150 mL increase in predose FEV1 vs
placebo at Week 24 Graph showing 291 mL increase in peak FEV1 vs placebo at Week 24 FEV at 5 mins vs placebo

All study treatments administered BID.

All study treatments administered BID.

All study treatments administered BID.

  • There was also an increase from baseline in predose FEV1 at Week 24 for BEVESPI AEROSPHERE vs glycopyrrolate 18 mcg (59 mL) and formoterol fumarate 9.6 mcg (64 mL) (both P<0.0001).1,2 Statistically significant improvement in morning predose FEV1 was also demonstrated in Trial 21,2
  • Adverse reactions with BEVESPI AEROSPHERE with a ≥2% incidence and more common than placebo were urinary tract infection and cough1†
  • *Improvements in lung function relative to its individual components and placebo in two 24-week pivotal trials.

All study treatments administered BID.

  • Secondary endpoint: In Trial 1, there were significant improvements from baseline at Week 24 in peak FEV1 for BEVESPI AEROSPHERE vs glycopyrrolate 18 mcg BID, formoterol fumarate 9.6 mcg BID, and placebo (P<0.0001 for all).1,2 Statistically significant improvement in peak FEV1 was also demonstrated in Trial 21,2
  • Adverse reactions with BEVESPI AEROSPHERE with a ≥2% incidence and more common than placebo were urinary tract infection and cough1
  • *Improvements in lung function relative to its individual components and placebo in two 24-week pivotal trials.

All study treatments administered BID.

  • In Trial 1, the mean increase in FEV1 at 5 minutes after the first dose vs placebo (n=172) was 187 mL for BEVESPI AEROSPHERE (n=418), 44 mL for glycopyrrolate 18 mcg (n=363), and 184 mL for formoterol fumarate 9.6 mcg (n=366). The mean increase in FEV1 at 120 minutes after the first dose vs placebo (n=218) was 260 mL for BEVESPI AEROSPHERE (n=523), 136 mL for glycopyrrolate 18 mcg (n=448), and 229 mL for formoterol fumarate 9.6 mcg (n=441) (P<0.0001 for all)1,2
  • Statistically significant improvement in FEV1 at 5 minutes was also demonstrated in Trial 21,2‡
  • Adverse reactions with BEVESPI AEROSPHERE with a ≥2% incidence and more common than placebo were urinary tract infection and cough1
  • *Improvements in lung function relative to its individual components and placebo in two 24-week pivotal trials.1,2
Through the breathing cycle, from expiration through inspiration.
In Study A BEVESPI AEROSPHERE helped patients get nearly 20% MORE AIR into their lungs5

BEVESPI AEROSPHERE is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

FROM EXPIRATION…

Achieved ~300 mL improvement in peak FEV1 vs placebo3

Two separate Phase IIIb clinical trials evaluated the efficacy and safety of BEVESPI compared with placebo (Study A, n=35; Study B, n=75)3

  • Primary endpoint: Mean improvements in FEV1 AUC0-24 on Day 29 for BEVESPI vs placebo were 249 mL and 265 mL (for Study A and Study B, respectively; both P<0.0001)
  • Secondary endpoint: Mean changes from baseline in peak FEV1 on Day 29 (evening) for BEVESPI vs placebo were 293 mL and 337 mL (for Study A and Study B, respectively; P<0.0001)3

…THROUGH INSPIRATION

Achieved a 381 mL improvement in peak inspiratory capacity vs placebo3

  • Secondary endpoint (continued): Mean improvements in peak IC from baseline on Day 29 (evening) for BEVESPI vs placebo were 381 mL (19.4%) and 312 mL (16.5%) (for Study A and Study B, respectively; both P<0.0001)4,5||¶
  • Adverse events were numerically similar across treatment arms3

All study treatments were administered BID.