AUTH/3260/10/19 - Complainant v GlaxoSmithKline

Promotion of Trelegy

  • Received
    14 October 2019
  • Case number
  • Applicable Code year
  • Completed
    03 August 2020
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK health professional, complained about an advertisement (ref UK/TLY/0035/17K) for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) placed on the Primary Care Respiratory Society website by GlaxoSmithKline UK Limited in November 2018. The advertisement depicted the Trelegy inhaler in the bottom right hand corner of the screen. In the centre of the screen was the headline ‘Less to take. More to take in’. This was followed by the two claims ‘The only COPD triple therapy delivered in a single daily inhalation’ and ‘Improvement in quality of life vs ICS/LABA’.

The complainant noted that the claim ‘Improvement in quality of life vs ICS/LABA’ referenced the FULFIL clinical trial (Lipson et al 2017) which only compared Trelegy Ellipta with AstraZeneca’s Symbicort Turbohaler (budesonide (ICS)/formoterol (LABA)); no other ICS/LABA combination was assessed. The complainant stated that, in essence, the claim was very general whereas the evidence base was very specific.

The detailed response from GlaxoSmithKline is given below.

The Panel considered that the claim that Trelegy Ellipta demonstrated ‘Improvements in quality of life vs ICS/LABA’ unequivocally implied that the medicine improved quality of life in COPD patients compared with all ICS/LABA combinations. The Panel noted that the claim was referenced to the FULFIL clinical trial (Lipson et al 2017) which compared Trelegy Ellipta with AstraZeneca’s Symbicort Turbohaler (budesonide (ICS)/formoterol (LABA)). The Panel noted GlaxoSmithKline’s submission that FULFIL was the only trial referenced alongside the claim because it was the main study which referenced QoL as a primary endpoint.

The Panel noted that the complainant had stated that the study cited in support of the claim was very specific whereas the claim was general. In that regard, the Panel noted that, where references were required, companies did not have to cite every study which supported a claim but they must be able to substantiate the claim and provide the relevant data if called upon to do so.


In the Panel’s view, the claim for Trelegy Ellipta of ‘Improvement in quality of life vs ICS/LABA’ implied that there was evidence to support an improvement in QoL with Trelegy Ellipta when compared with all ICS/LABA combinations for COPD which was not so. The Panel noted that with regard to QoL Trelegy Ellipta had been directly and favourably compared with budesonide/formoterol in the FULFIL study (primary endpoint) and with fluticasone/valenterol in the IMPACT study (secondary outcome). The Panel noted, however, that Calverley et al (2010) compared Fostair (beclomethasone/formoterol) with Symbicort (budesonide/formoterol) rather than Trelegy Ellipta and showed Fostair to be non-inferior to Symbicort in terms of QoL improvement. There was thus only indirect evidence to show that Trelegy Ellipta would be likely to improve QoL more than beclomethasone/formoterol based on the data extrapolated from Caverley et al (2010). The Panel considered that although there was favourable data with regards to QoL for Trelegy Ellipta from direct comparisons with some of ICS/LABA combinations, it was not clear that with regards to Fostair, the claim was based on extrapolated data. There was also no data with which to compare Trelegy Ellipta and fluticasone propionate/salmeterol (eg GlaxoSmithKline’s Seretide).

The Panel considered that the claim did not reflect the evidence clearly and that the comparison was misleading and incapable of substantiation and breaches of the Code were ruled.