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Your choice of COPD maintenance therapy could make a difference to your patients

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

*This single-visit study conducted in 56 primary and speciality care centres in the USA investigated symptom burden, QoL and comorbidity in COPD patients receiving maintenance therapy with long-acting bronchodilator (LABD) monotherapy. The study found that 64% (n=689) of patients enrolled had spirometry consistent with a diagnosis of COPD and of these, 77%, 15% and 8% were using tiotropium, formoterol and salmeterol, respectively. Regardless of the severity of lung function impairment, the study found that approximately 50% of patients on LABD monotherapy had mMRC scores ≥2.2

Are any of your patients on maintenance monotherapy still suffering from breathlessness?
Or still experiencing symptoms?

How does Anoro Ellipta (a LAMA/LABA) compare with tiotropium HandiHaler (a LAMA) for improvement in trough FEV1?

In a pooled, post-hoc analysis of three 24-week RCTs in patients not on maintenance therapy (for ≥30 days before screening), Anoro Ellipta demonstrated a 2.4x greater lung function improvement vs. tiotropium HandiHaler (with an extra 146mL improvement in trough FEV1)3,4

Change in trough FEV1 at day 169

Graph demonstrating an 146mL improvement in lung function Image demonstrating an 146mL improvement in lung function

LS, least squares; RCT, randomised controlled trial;
MCID (minimum clinically important difference) = 100mL

Adapted from Maleki-Yazdi et al. 20163

  • 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

What could an improvement in lung function mean for your COPD patients?

patient reported outcomes

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

*LAMA, LABA and the LAMA/LABA Ultibro.1

What could an improvement in lung function mean for your COPD patients?

Image showing the reduction in rescue medication use

How does Anoro Ellipta (a LAMA/LABA) compare with tiotropium HandiHaler (a LAMA) for reduction in rescue medicine use?

In two (out of three) individual 24-week RCTs in COPD patients not on maintenance therapy at the study screening visit, Anoro Ellipta significantly reduced rescue medication use vs. tiotropium HandiHaler*5,6

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. 20145

Decramer et al. 20146

Image showing the association between increases in trough FEV1 and SGRQ & TDI Image showing the association between increases in trough FEV1 and SGRQ & TDI

LS, least squares; NS, not statistically significant.
*LABA, tiotropium, and ICS/LABA therapies were stopped ≥2 days, ≥14 days and ≥30 days before screening visit, respectively.
 **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.

  • 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

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Dosing & the Ellipta device

NICE COPD Guidelines

Molecules

Head-to-head data vs. LAMA/LABAs

References

  1. Donohue JF et al. Pulm Pharmacol Ther 2018;49:11–19.
  2. Dransfield MT, et al. Prim Care Respir J 2011; 20:46–53
  3. Maleki-Yazdi M et al. Adv Ther 2016; 33:2188–2199
  4. GSK data on file RF/UCV/0112/15
  5. Maleki-Yazdi MR et al. Respir Med 2014;108:1752–1760
  6. 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.

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PM-GB-UCV-WCNT-200037 May 2021