Lung function improvements

SPIOLTO® RESPIMAT® provides significant improvements in lung function within 5 minutes of the first dose, lasting at least 24 hours.1,2

SPIOLTO® RESPIMAT® demonstrated consistent lung function improvements versus monotherapy and placebo, with the greatest improvements seen in GOLD 2 and in maintenance-naïve patients.3 

SPIOLTO® RESPIMAT® provided significant improvement in 24-hour FEV1 vs placebo and its monotherapies SPIRIVA® (tiotropium) and STRIVERDI® (olodaterol).1*

FEV1 profiles over 24 hours1†

 

Adapted from reference 1

p<0.0001 for all comparisons of SPIOLTO® RESPIMAT® vs monotherapies and placebo

* data presented here are the mean results in the overall study population.

24-hour FEV1 profiles after 6 weeks of treatment

Lung function improvement in GOLD 2 patients

In a study with SPIOLTO® RESPIMAT® (tiotropium/olodaterol) lung function improvement in GOLD 2 COPD patients was twice as high compared to monotherapy with SPIRIVA®.3

Adapted from reference 3

†  Post hoc subgroup analysis of the TONADO® studies. The primary endpoints of the TONADO® studies were FEV1AUC0-3, trough FEV1, and SGRQ total score in patients with a history of moderate to very severe COPD (stage 2-4).

*  p<0.0001

LABD= long acting bronchodilator

Improved lung function versus LABA/ICS

SPIOLTO® RESPIMAT® improved lung function across 24 hours significantly better than LABA/ICS.4

FEV1 profiles over 24 hours4*‡

Adapted from reference 4

In the ENERGITO® study, majority of patients (72%) had GOLD 2 lung function impairment

Primary endpoint: Change from baseline in FEV1 AUC0-12h after 6 weeks of treatment with either once-daily SPIOLTO® RESPIMAT® or twice daily fluticasone propionate/salmeterol; FDC delivered by Accuhaler®; Secondary endpoints included: FEV1 AUC0–24h, FEV1 AUC12–24h, peak0–3h FEV1 response, and trough FEV1 response.
*adjusted mean 24-hour FEV1 profile after 6 weeks of treatment; The starting point for the Y axis is 1.20.

‡the starting point for the Y axis is 1.20.

In patients with GOLD 2-3 stage disease, SPIOLTO® RESPIMAT® provided 69% improvement in FEV1,
AUC0-12h  over twice daily salmeterol/fluticasone 50/500 mcg4**

** The 69% result is based on the change from baseline4

Reduction in hyperinflation

SPIOLTO® RESPIMAT® significantly reduced hyperinflation vs SPIRIVA® and placebo. The positive effects on lung volume were maintained over the full 24 hr dosing period.1

References

  1. Beeh KM, et al. Pulm Pharmacol Ther 2015;32:53-59.
  2. SPIOLTO® RESPIMAT® Summary of Product Characteristics February 2017.
  3. Ferguson GT, et al. Adv Ther 2015;32:523-536 and supplementary information.
  4. Beeh KM, et al. Int J Chron Obstruct Pulmon Dis 2016;11:193-205.