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Información médica

Efficacy

Greater improvement in lung function vs. tiotropium 1

Once-daily Incruse provided a significantly greater trough FEV1 improvement of 59 mL from baseline vs. tiotropium HandiHaler® (154 mL vs. 95 mL; p<0.001) at Day 85 1

Change from baseline in trough FEV1 at Day 85 1

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Adapted from Feldman et al. 2016 1

FEV1, forced expiratory volume in 1 second.

  • Study design

    Data from a 12-week, randomised, blinded, double-dummy, parallel-group study. Patients were required to have a mean predicted FEV1 of ≥30% and ≤70% at baseline. Least squares (LS) mean change from baseline at Day 85 was 154 mL for Incruse and 95 mL for tiotropium HandiHaler®. 1 Primary endpoint: trough FEV1 on Day 85. Data are for the per-protocol population. 1 Details of the blinding process for the tiotropium comparator study discussed here can be found on page 1 of Supplementary Material, Feldman G et al. Int J Chron Obstruct Pulmon Dis 2016; 11:719–730.

Improved efficacy from baseline vs. tiotropium 1

Once-daily Incruse significantly improved 12–24h weighted mean FEV1 vs. tiotropium HandiHaler® (145 mL vs. 138 mL; p=0.015) 1

Change from baseline in serial FEV1 over 0–24h post-dose on Day 84 1

Adapted from Feldman et al. 2016 1

FEV1, forced expiratory volume in 1 second.

  • Study design

    Data from a 12-week, randomised, double-blind, double-dummy, parallel-group study. Patients were required to have a mean predicted FEV1 of ≥30% and ≤70% at baseline. Weighted mean FEV1 12–24h was a secondary endpoint. Data are for the 24-hour population (all patients in the intent-to-treat population for whom 24-hour spirometry was performed). 1 Details of the blinding process for the tiotropium comparator study discussed here can be found on page 1 of Supplementary Material, Feldman G et al. Int J Chron Obstruct Pulmon Dis 2016; 11:719–730.

Non-inferiority vs. the LAMA glycopyrronium 3

Once-daily Incruse showed non-inferiority compared with glycopyrronium Breezhaler® (trough FEV1 at Day 85 treatment difference: 24 mL, 95% CI: -5–54) 3

Change from baseline in trough FEV1 3

Adapted from Rheault et al. 2016 2

CI, confidence interval; FEV1, forced expiratory volume in 1 second.

  • Study design

    Data from a 12-week, multicentre, randomised, open-label, parallel-group study. Patients were required to have a mean predicted FEV1 of ≥30% and ≤70% at baseline. Least squares (LS) mean change from baseline at Day 85 was 123mL for Incruse and 99mL for glycopyrronium Breezhaler®. 2 Primary endpoint: trough FEV1 on Day 85. Data are for the per-protocol population.

Improved health-related quality of life vs. placebo 5

Treatment with Incruse Ellipta resulted in clinically meaningful improvement of 4.7 units in SGRQ total score vs. placebo on Day 168 (-7.25 vs. -2.56; p<0.001) 5

Change from baseline in SGRQ total score on Day 168 5

Adapted from Donohue et al. 2013

SGRQ, St George’s Respiratory Questionnaire.

  • Study design

    Data from a 24-week, randomised, double-blind, double-dummy, parallel-group study. Patients were required to have a mean predicted FEV1 of ≥30% and ≤70% at baseline. Primary endpoint: trough FEV1 on Day 169. SGRQ score was a secondary endpoint. 4 A step-down statistical procedure was used in this study and this outcome was below an endpoint that did not achieve statistical significance; therefore statistical significance on this comparison cannot be inferred.

Improved COPD symptoms vs. placebo 5

Incruse Ellipta demonstrated clinically meaningful improvement of 1.0 unit in TDI focal score vs. placebo on Day 168 (2.2 vs. 1.2 units; p≤0.001) 5

Change from baseline in TDI focal score on Day 168 5

Adapted from Donohue et al. 2013 4

TDI, Transition Dyspnoea Index

  • Study design

    Data from a 24-week, randomised, double-blind, double-dummy, parallel-group study. Patients were required to have a mean predicted FEV1 of ≥30% and ≤70% at baseline. Primary endpoint: trough FEV1 on Day 169. TDI focal score was a secondary endpoint. 4

References:

  1. Feldman G et al. Int J Chron Obstruct Pulmon Dis 2016; 11:719–730.
  2. Feldman G et al. Int J Chron Obstruct Pulmon Dis 2016; 11:719–730 (supplementary material).
  3. Rheault T et al. ERJ Open Res 2016;2: pii:00101-2015.
  4. Ismaila AS et al. Int J Chron Obstruct Pulmon Dis 2015; 10:2495–2517.
  5. Donohue JF et al. Respir Med 2013; 107:1538–1546.

INCRUSE™ ™ y ELLIPTA™ Instructivo son marcas registradas del grupo de compañías GlaxoSmithKline