2007 GOLD Report—LAMA/LABAs now recommended 1st-line for most patients. 2007 GOLD Report—LAMA/LABAs now recommended 1st-line for most patients.

MAXIMIZE BRONCHODILATION*

 

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

*Improvements in lung function relative to its individual components and placebo in two 24-week pivotal trials.1,2

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

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

Predose FEV1 vs placebo Peak FEV1 vs placebo FEV at 5 mins vs placebo Patient with improved inspiratory capacity. Not an actual patient. Patient with improved inspiratory capacity. Not an actual patient.
 
 
 
Predose FEV1 vs placebo Peak FEV1 vs placebo FEV at 5 mins vs placebo Patient with improved inspiratory capacity. Not an actual patient. Patient with improved inspiratory capacity. Not an actual patient.

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.1,2
  • Initial treatment in Group B patients with severe breathlessness and in Group D patient.3

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.1,2
  • Initial treatment in Group B patients with severe breathlessness and in Group D patient.3

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

This means BEVESPI AEROSPHERE helped patients get nearly 20% more air into their lungs3,4

Two separate Phase IIIb clinical trials evaluated the efficacy of BEVESPI AEROSPHERE 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 AEROSPHERE vs placebo were 249 mL and 265 mL (for Study A and Study B, respectively; both P<0.0001)3‡
  • Secondary endpoint: Mean improvements in peak inspiratory capacity from baseline on Day 29 (evening) for BEVESPI AEROSPHERE vs placebo were 381 mL (19.4%) and 312 mL (16.5%) (for Study A and Study B, respectively; both P<0.0001)3,4§¶
  • Adverse events were numerically similar across treatment arms
  • Initial treatment in Group B patients with severe breathlessness and in Group D patient.5