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Relvar and cortisol levels

For inhaled corticosteroids, measuring cortisol suppression is the most sensitive and easily monitored biomarker of adverse systemic effects.1

The maximum ICS dose licensed with Relvar is substantially lower than that estimated for 20% cortisol suppression.*1 In fact, geometric mean 24-hour serum cortisol has been shown to be similar after 42 days of treatment with Relvar to that seen with placebo.2

Maximum licensed dose in ICS/LABA therapy and dose estimated to cause 20% cortisol suppression based on pharmacological modelling data1

cortisol levels graph

This graph has been independently created by GSK from the original data. The same results were first published in Daley-Yates PT. Br J Clin Pharmacol 2015;80:372–380.
Fluticasone furoate is not licensed for use as monotherapy.

24-hour serum cortisol at Day 42 of treatment

HPA graph

This graph has been independently created by GSK from the original data. The same results were first published in Allen A, et al. Clin Respir J 2013;7:397–406.

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*Indirect data comparison based on PK/PD modelling. The model uses 20% cortisol suppression as the lowest boundary of detectable systemic exposure for corticosteroids, serving as a cut-off point above which the adverse events of corticosteroids become more likely.1


DPI, dry powder inhaler; FF, fluticasone furoate; HFA, hydrofluoroalkane; HPA, hypothalamicpituitary-adrenal; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; OD, once daily; PD, pharmacodynamic; PK, pharmacokinetic.

  1. Daley-Yates PT. Br J Clin Pharmacol 2015;80:372–380.
  2. Allen A, et al. Clin Respir J 2013;7:397–406.
  3. Global Datasheet Fluticasone furoate/vilanterol: v11, March 2020.
  4. Symbicort 400/12 Turbohaler SmPC, 2020.
  5. Seretide 500 Accuhaler SmPC, 2020.
  6. Fostair 200/6 NEXThaler SmPC, 2019.

RELVAR Ellipta was created in collaboration with

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Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: . Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Relvar is a registered trademark of the GlaxoSmithKline group of companies

A.G. Last updated: May 2021 PM-IE-FFV-WCNT-210005