Improving lung function and reducing breathlessness may have a positive effect on your patients' quality of life1
This is a fictional patient for illustrative purposes.
Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
Did you know, five out of ten COPD patients reported significant breathlessness (mMRC≥2) despite maintenance therapy with a long-acting mono-bronchodilator*2
Are any of your patients on maintenance monotherapy still suffering from breathlessness?
Or still experiencing symptoms?
Change in trough FEV1 at day 169
Maleki-Yazdi et al. 2016 study details
Post hoc, pooled analysis of 3 multicentre, parallel group, RCTs at 24 weeks in symptomatic patients not on maintenance therapy (for ≥ 30 days before screening).3,4
Patients had an mMRC score ≥ 2 and a post-bronchodilator FEV1 of ≤ 70% predicted.3,4
Trough FEV1 improvement from baseline of 252mL for Anoro (n=230) vs 107mL for tiotropium HandiHaler (n=216); difference 146mL (95% CI: 102-189; p<0.001).3,4
Anoro Ellipta was well tolerated, with a comparable safety profile to tiotropium HandiHaler.3
A post hoc, pooled analysis of 23 RCTs of long-acting bronchodilators* in COPD (n=23, 213) found that improvements in trough FEV1 post bronchodilator therapy were associated with improvements in patient-reported outcomes (PROs) such as St George's Respiratory Questionnaire (SGRQ) and Transition Dyspnoea Index (TDI)1
What could an improvement in lung function mean for your COPD patients?
How does Anoro Ellipta (a LAMA/LABA) compare with tiotropium HandiHaler (a LAMA) for reduction in rescue medicine use?
Change in rescue medication use (an additional efficacy endpoint) in three 24-week RCTs (in which the primary endpoint was trough FEV1)*
Maleki-Yazdi et al. 2014 & Decramer et al. 2014 study details
These three 24-week RCTs of Anoro Ellipta vs. tiotropium HandiHaler had blinded, double-dummy, parallel group designs, whereby patients were given 2 inhalers (one contained active drug and the other placebo) and patients and physicians were masked to assigned treatment. However, the blinding process had limitations as whilst patients and physicians were masked to assigned treatment, tiotropium capsules (also, blister packs and inhalers) had markings not present on the placebo capsules. Labels were used to cover identifying information/markings on blister packs/inhalers and all studies had a parallel-group design so capsule type, blister packs and inhalers were consistent for patients for the study duration. Staff involved with efficacy and safety assessments were also absent from dosing in the clinic to guard against the possibility of them identifying which capsules the patient was receiving and making correct inferences.5,6
A stepdown hierarchical statistical procedure was used in the 3 RCTs such that the statistical significance of a given test was dependent on the significance of the preceding tests in the pre-defined hierarchy. If any of the preceding tests were non-significant, subsequent tests would also be regarded as non-significant regardless of the p value achieved.5,6
The primary endpoint in these studies was trough FEV1 at Day 169. Rescue medicine use was an additional efficacy endpoint.5,6
- Donohue JF et al. Pulm Pharmacol Ther 2018;49:11–19.
- Dransfield MT, et al. Prim Care Respir J 2011; 20:46–53
- Maleki-Yazdi M et al. Adv Ther 2016; 33:2188–2199
- GSK data on file RF/UCV/0112/15
- Maleki-Yazdi MR et al. Respir Med 2014;108:1752–1760
- Decramer M et al. Lancet Respir Med 2014;2:472–486.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ .
Adverse events should also be reported to GlaxoSmithKline UK on 0800 221 441.
© 2021 GSK group of companies or its licensor.
ANORO was developed in collaboration with INNOVIVA.
Trademarks are owned by or licensed to the GSK group of companies.
PM-GB-UCV-WCNT-200037 May 2021