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The Salford Lung Study in COPD

Pioneering UK trial answers, how Relvar can benefit COPD patients you see every day. Read the detailed results below.

The primary comparison was Relvar 92/22 mcg (n=1,135) vs. usual care (n=1,134)[2]. The analysis was based on a modifed ITT (mITT) population of patients with ≥1 exacerbation in the year prior to randomisation[1].

β Usual care was a physician-determined COPD maintenance treatment in accordance with usual clinical practice. The intention was to keep the treatment experience as close to normal as possible. Of all mITT patients with ≥1 exacerbation in the year prior to randomisation (n=2,269, i.e. 81% of the total number of patients included in the study), at baseline: 88% were on an ICS-containing regimen, 54% were on triple therapy (a combination of ICS/LABA+LAMA) and 12% were on a LABA and/or LAMA only[1].

In the study, the intention-to-treat (ITT) population consisted of 2,799 randomised patients who received ≥1 prescription of study medication. The primary endpoint was the mean annual rate of moderate/severe COPD exacerbations in the primary effectiveness analysis (PEA) population (n=2,269). The PEA were a subset of the entire ITT population who had experienced ≥ 1 moderate/severe COPD exacerbation in the preceding year and were randomised to either Relvar Ellipta* 92/22 mcg (fluticasone furoate/vilanterol Relvar Ellipta 92/22 mcg OD) or continuation on their usual care.[1]**

Subset of patients randomised to an ICS/LABA ± LAMA strata and were taking an ICS/LABA at baseline [1].

Key results

Primary comparison was Relvar Ellipta (n=1,135) vs. usual care** (n=1,134)[2]. The rate of moderate/severe exacerbations was 1.74 exacerbations per year in the Relvar Ellipta 92/22 mcg group, compared with 1.90 per year in the usual care group, indicating an 8.4% (95% CI: 1.1, 15.2; p=0.02) reduction in the Relvar Ellipta 92/22mcg OD group[1].

Once-daily Relvar 92/22 mcgα resulted in significantly fewer moderate/severe COPD exacerbations compared with usual care[1]βPatients could receive a LAMA throughout the treatment period, in addition to their randomised treatment, if their doctor felt this was appropriate for the patient.

In addition, once-daily Relvar (92/22 mcg) significantly reduced moderate/severe COPD exacerbations compared with twice-daily ICS/LABA (95% CI: 0.11, 15.4; p=0.047) with a high proportion on Seretide[1]*†.

Figure 1. Once-daily Relvar 92/22 mcg significantly reduced moderate/severe COPD exacerbations compared with twice-daily ICS/LABA[1]α of which a high porportion were on Seretide.

Once-daily Relvar 92/22 mcg significantly reduced moderate/severe COPD exacerbations compared with twice-daily ICS/LABA graph

α Patients could receive a LAMA throughout the treatment period in addition to their randomised treatment. Subset of patients randomised to an ICS/LABA ± LAMA strata and were taking an ICS/LABA at baseline, with a high proportion on fluticasone propionate/salmeterol.[1]

The New England Journal of Medicine (NEJM) 2016 publication of the Salford Lung Study in COPD is available to view from their website below (GSK does not own and is not responsible for the content of this site):

Go to NEJM website

 

Results from other endpoints

In addition to the primary endpoint results, significantly more patients achieved an improvement in their COPD-related health status with Relvar 92/22 mcg*, compared with usual care,[1]** as measured by the COPD Assessment Test (CAT).‡

Figure 2. More patients achieve CATα score improvement of ≥2 units with Relvar β, compared with usual care[1]δγ
 

More patients achieve CAT score improvement of ≥2 units with Relvar, compared with usual care graph

β Patients could receive a LAMA throughout the treatment period in addition to their randomised treatment.[1]

γ Analysis based on patients who completed CAT questionnaire at baseline and at month 12 (i.e. usual care† n=1,325; FF/VI n=1,317).[1]

ICS/LABA = inhaled corticosteroid/long-acting β2-adrenoceptor agonist; LAMA = long-acting muscarinic antagonist; NNT = numbers needed to treat; CAT = COPD Assessment Test

Additional effectiveness results

The study also demonstrated:

  • No significant difference between Relvar Ellipta 92/22 mcg and usual care** in reduction of the mean annual rate of severe exacerbations (0.09 and 0.08 exacerbations per year, respectively, p=0.52).[1]

  • No significant difference between Relvar Ellipta 92/22 mcg and usual care** in the time to first moderate/severe exacerbation; hazard ratio: 0.93 (0.85, 1.02) and in the time to first severe exacerbation; hazard ratio: 1.27 (0.98, 1.66; p=0.08) in the entire study population.[1]

  • No difference between Relvar Ellipta 92/22 mcg and usual care** in COPD-related contacts with primary care.[1]

  • A 12.3% increase (95% CI: 5.4, 19.6) in the annual rate of all primary care contacts in the Relvar Ellipta 92/22 mcg group.[1]

  • No difference between Relvar Ellipta 92/22 mcg and usual care** in the rate of secondary healthcare contacts.[1]

Safety results

Overview of safety in a population of patients receiving Relvar 92/22 mcg compared to usual care** in everyday clinical practice[1]

  • 29% of patients in the Relvar Ellipta 92/22 mcg group and 27% in the usual care** group experienced an on-treatment SAE

  • There was no notable difference between treatment groups for any adverse event of specific interest (AESI)

  • 45 patients in the Relvar Ellipta 92/22 mcg group and 30 patients in the usual care** group died during the study

  • One patient death in each group was recorded as being related to the trial medication (pneumonia in 1 patient in the usual care** group, and pulmonary embolism/deep-vein thrombosis in patient in the Relvar Ellipta 92/22 mcg group)

Figure 4. Relvar 92/22 mcg is associated with an incidence of on-treatment pneumonia no greater than usual care[1]α

Relvar 92/22 mcg is associated with a comparable incidence of on-treatment pneumonia compared to usual care

The non-inferiority margin for the ratio of the proportions with pneumonia on Relvar Ellipta 92/22 mcg versus usual care is set at 2.

Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio Relvar Ellipta 92/22 mcg usual care is less than 2.

In common with other ICS-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Relvar 92/22 mcg.[3]

Dr David Leather, Medical VP - Global Respiratory Franchise, GSK UK

What does it mean for you and your patients?

“The Salford Lung Study in COPD is going to benefit patients in a number of ways – not just by demonstrating that Relvar 92/22 mcg can bring real benefits (i.e. reducing the rate of moderate/severe COPD exacerbations and improving disease-related health status) but also in the immense mass of data we’ve got in this study that will help us understand just how patients with COPD, and their doctors, and their healthcare systems, behave.”

— Dr David Leather, Medical VP – Global Respiratory Franchise, GSK, UK.

The data from the Salford Lung Study COPD provides new and valuable insights into COPD treatments and outcomes, including how Relvar 92/22 mcg compares with other commonly-used COPD maintenance treatments and how it can benefit the patients that healthcare professionals see in their practice every day.[1]

The Salford Lung Study COPD showed that Relvar 92/22 mcg reduced the annual rate of moderate/severe exacerbations by 8.4% (p=0.02) compared with usual care and could have a comparable safety profile to other COPD treatments in a population more representative of the patients with COPD you see in your everyday clinical practice.[1] The only ICS/LABA that provides 24-hour continuous efficacy in a once-daily dose, Relvar is delivered through Ellipta®, an inhaler associated with higher patient preference and fewer critical errors§ compared with other commonly used inhalers after reading PIL.[3],[8]–[10]

To learn more about how Relvar can benefit the patients with COPD you see in your everyday practice, please click the button below to watch the short video on our Respiratory knowledge base page from Dr David Leather on the Salford Lung Study - study design and results.

Watch the video

LABA = long-acting β2-adrenoceptor agonist; ICS/LABA=inhaled corticosteroid/long-acting β2-adrenoceptor agonist; LAMA = long-acting muscarinic antagonist; NNT=number needed to treat; PEA=primary effectiveness analysis; ITT=intention-to-treat.

* Patients could receive a LAMA throughout the treatment period in addition to their randomised treatment. Subset of patients randomised to an ICS/LABA ± LAMA strata and were taking an ICS/LABA at baseline.[1]

**Usual care was a physician-determined COPD maintenance treatment in accordance with usual clinical practice. The intention was to keep the treatment experience as close to normal as possible. Of all mITT patients with ≥1 COPD exacerbation in the year prior to randomisation (n=2,269, i.e. 81% of the total number of patients included in the study), at baseline: 88% were on an ICS-containing regimen, 54% were on triple therapy (a combination of ICS/LABA+LAMA) and 12% were on a LABA and/or LAMA only.[1]

† The primary comparison was Relvar (n=1,135) vs. usual care (n=1,134).[2] The analysis was based on the mITT population with ≥1 moderate/severe COPD exacerbation in the year prior to randomisation.[1]

‡ CAT: COPD Assessment test (a questionnaire designed to measure the impact of COPD on a patient’s wellbeing and daily life).[4] Quality of life was measured via the European Quality of Life-5 Dimensions questionnaire).[1]

§ Critical errors defined as errors that are likely to result in no or minimal medication being inhaled.[10]

References

  1. Vestbo J et al. Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. NEJM 2016. DOI: 10.1056/NEJMoa1608033.
  2. Vestbo J et al. Supplement to effectiveness of fluticasone furoate-vilanterol for COPD in clinical practice. NEJM 2016: DOI: 10. 1056/NEJMoa1608033:1–13.
  3. Relvar Ellipta 92/22 mcg Summary of Product Characteristics. GlaxoSmithKline; 2016.
  4. Kon SSC et al. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014; 2: 195–203.
  5. COPD Assessment Test (CAT). Available online at: http://www.catestonline.org/images/pdfs/CATest.pdf [last accessed: December 2016]
  6. Jones PW. COPD assessment test – rationale, development, validations and performance. COPD. 2013; 10: 269-271.
  7. Boscia JA et al. Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, crossover study. Clin Ther. 2012; 34(8): 1655–1666.e5.
  8. Svedsater H et al. Qualitative assessment of attributes and ease of use of the ELLIPTA™ dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013; 13:72.
  9. Riley JH et al. Correct usage, ease of use and preference of two dry powder inhalers in patients with COPD: analysis of five phase III randomized trials. Int J Chron Obstruct Pulmon Dis. 2016; 11: 1873–1880.
  10. van der Palen, J et al.Inhaler errors after reading the patient information leaflet in patients with COPD; A comparison of Ellipta with five inhaler devices. Am J Respir Crit Care Med 2016; 193: A6811.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to GlaxoSmithKline UK on 0800 221 441.

Relvar, Seretide and Ellipta are registered trademarks of the GlaxoSmithKline group of companies 

S.W. December 2016. UK/FFT/0116/16