Pneumologie 2019; 73(S 01)
DOI: 10.1055/s-0039-1678225
Posterbegehung (P18) – Sektion Klinische Pneumologie
Klinische Studien bei COPD, Asthma, Palliativmedizin & more
Georg Thieme Verlag KG Stuttgart · New York

The duration of anti-inflammatory action of fluticasone furoate (FF) assessed via exhaled nitric oxide (FeNO) in asthmatics following administration of FF/vilanterol (VI)

G Bardsley
1   Medical Research Institute of New Zealand, Wellington
,
P Daley-Yates
2   Respiratory Clinical Development, Glaxosmithkline Research and Development, Stockley Park, UK
,
A Baines
3   New Zealand Medicines Research Centre, Glaxosmithkline Research and Development, Stevenage, UK
,
K Riddell
4   Glaxosmithkline Research and Development, Ermington Nsw 2115, Australia
,
S Joshi
5   Glaxosmithkline Research and Development, Biostatistics and Programming, Bangalore, India
,
P Bareille
3   New Zealand Medicines Research Centre, Glaxosmithkline Research and Development, Stevenage, UK
,
R Beasley
1   Medical Research Institute of New Zealand, Wellington
,
J Fingleton
1   Medical Research Institute of New Zealand, Wellington
› Author Affiliations
Further Information

Publication History

Publication Date:
19 February 2019 (online)

 

FF is an inhaled corticosteroid (ICS) with higher glucocorticoid receptor (GR) affinity and greater lung retention compared to other ICS. We investigated whether these attributes confer a prolonged duration of anti-inflammatory action.

This was a randomised, double-blind, placebo-controlled, two-period, crossover study in 27 adults with asthma (GSK Protocol 201 499). Following screening, subjects with FEV1 ≥ 60% predicted, reversible airway disease and FeNO > 40ppb, received FF/VI 100 µg/25 µg or placebo via an Ellipta inhaler once daily for 14 days. FeNO measurements (NIOX Vero device) were made AM and PM for 14 days during treatment and for 21 days after treatment in each period (≤ 4 weeks elapsed between periods). Peak expiratory flow (PEF) was measured AM & PM from day −7 to 35.

Following cessation of treatment FeNO remained suppressed for ≈ 18 days and improvements in PEF were maintained for 3 – 4 days. No SAEs were observed.

In contrast, a similar study with budesonide (Thorax 2002;57 : 889) reported rapid and complete reversal of FeNO suppression ≤ 7days following 3 wks of treatment with 400 µg/day. The long duration of anti-inflammatory action of FF observed in this study appears consistent with its high GR affinity and lung retention and was notably longer than the 3 day duration of bronchodilation observed with FF/VI.

This poster will be presented as an ENCORE. It has been presented at ERS 2017 in Milan.

GSK funded (201 499; NCT02712047)