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Bronchoprotection

A modelling study has unlocked valuable insights into the bronchoprotection and systemic activity (cortisol suppression) profiles of FF and BUD across different dosing and adherence scenarios.1 Simulations were performed using a previously validated PK/PD model using data from published studies.2–4

At comparable adherence rates, FF/VI provided a more favourable bronchoprotective profile than both regular BUD/Form 200/6 µg and BUD/Form 400/12 µg regimens in models of moderate-to-severe asthma.*1

Time-without-bronchoprotection-graph Time-without-bronchoprotection-graph
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Time without bronchoprotection with the starting dose of FF/VI (100/25 μg OD) was ≤15%, even at 30% adherence, in a modelling study of moderate-to-severe asthma1

GSK does not promote low adherence when using its products. Bronchoprotection was defined as the ability of an ICS to prevent a drop of >20% in FEV1 in an AMP challenge test.2 These findings may not directly correlate to clinical outcomes in daily practice. Material from: ‘Peter Daley-Yates et al., Assessing the Effects of Changing Patterns of Inhaled Corticosteroid Dosing and Adherence with Fluticasone Furoate and Budesonide on Asthma Management, published 2023 Springer Nature reproduced with permission of SNCSC’. The original data were first published in Daley-Yates P, et al. Adv Ther 2023;40:4042–4059.

Fewer puffs graphic Fewer puffs graphic

Calculated by dividing the number of doses per 28 days for BUD/Form by the number of doses per 28 days for FF/VI. 74÷25 = 2.96 for BUD/Form MART 200/6 μg BD + PRN vs FF/VI 100/25 μg OD at 90% adherence. 58÷8 = 7.25 for BUD/Form MART 200/6 µg ×2 BD + PRN vs FF/VI 200/25 µg OD at 30% adherence.1
GSK does not promote low adherence when using its products. Bronchoprotection was defined as the ability of an ICS to prevent a drop of >20% in FEV1 in an AMP challenge test.2 These findings may not directly correlate to clinical outcomes in daily practice. This figure has been independently created by GSK. The original data were first published in Daley-Yates P, et al. Adv Ther 2023;40:4042–4059.

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Footnotes

*Favourable bronchoprotection profile defined as longer bronchoprotection and low systemic effects vs BUD/Form.1 Bronchoprotection was defined as the ability of an ICS to prevent a drop of >20% in FEV1 in an AMP challenge test.2 Cortisol suppression above 20% was considered an indicator of higher systemic activity.1 These findings may not directly correlate to clinical outcomes in daily practice.1 Study limitations: These results build on an earlier PK/PD modelling study, but assumptions on lung binding have not been directly validated by measurements in human lung tissue; the model only estimates the bronchoprotective effects of ICS through anti-inflammatory mechanisms; only widely available and twice daily ICS and ICS-containing regimens were included in the analysis; no statistical significance was associated with these findings and
p values were not calculated; future work is required to corroborate the current findings in clinical studies.1,4

Calculated by dividing the number of doses per 28 days for BUD/Form by the number of doses per 28 days for FF/VI. 74+25 = 2.96 for BUD/Form MART 200/6 μg BD + PRN vs FF/VI 100/25 μg OD at 90% adherence. 58+8 = 7.25 for BUD/Form MART 200/6 μg ×2 BD + PRN vs FF/VI 200/25 μg OD at 30% adherence.

Abbreviations

AE, adverse event; AMP, adenosine 5’-monophosphate; BD, twice daily; BUD, budesonide; DD, doubling dose; FEV1, forced expiration volume in 1 second; FF, fluticasone furoate; Form, formoterol; ICS, inhaled corticosteroid; MART, maintenance and reliever therapy; OD, once daily; PD, pharmacodynamics; PK, pharmacokinetics; PRN, as needed; VI, vilanterol.

Relvar Safety Information5

Contraindications
Hypersensitivity to the active substances or to any of the excipients.

Undesirable effects
Very Common: Headache, Nasopharyngitis.

Common: Infections and infestations, Oropharyngeal pain, Sinusitis, Pharyngitis, Rhinitis, Cough, Dysphonia, Abdominal pain, Arthralgia, Back pain, Fractures, Muscle spasms and Pyrexia.

References
  1. Daley-Yates P, et al. Adv Ther 2023;40:4042–4059.
  2. Daley-Yates P, et al. Adv Ther 2022;39:706–726.
  3. Daley-Yates P, et al. Br J Clin Pharmacol 2021;87:483–493.
  4. Singh D, et al. Adv Ther 2022;39:1895–1914.
  5. Relvar Prescribing Information.

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PM-RCH-FFV-WCNT-250001 Date of preparation: July 2025