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The first study included safety data from 911 patients with COPD who received doses of Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) 100/62.5/25 micrograms once daily for up to 24 weeks, of whom 210 patients received Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) 100/62.5/25 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).
The second study included safety data from 527 patients with COPD who received Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) 100/62.5/25 micrograms and 528 patients with COPD who received fluticasone furoate/vilanterol 100/25 micrograms + umeclidinium 62.5 micrograms once daily for up to 24 weeks (study 200812). The third study included safety data from 4,151 patients with COPD who received Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) 100/62.5/25 micrograms once daily for up to 52 weeks, with two active comparators (study CTT116855, IMPACT).
Where adverse reaction frequencies differed between studies, the higher frequency is reported as follows.
Adverse reactions are listed as follows by MedDRA system organ class and by frequency (Table 4). The following convention has been used for the classification of adverse reactions: Very common: ≥1/10; Common: ≥1/100 to <1/10; Uncommon: ≥1/1000 to <1/100; Rare: ≥1/10000 to <1/1000; Very rare: <1/10000. (See Table 4.)
Click on icon to see table/diagram/imageDescription of selected adverse reactions: *Pneumonia (see Precautions).
COPD: In a total of 1,810 patients with advanced COPD (mean post-bronchodilator screening FEV1 45% of predicted, standard deviation [SD] 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), a higher incidence of pneumonia events was reported in patients receiving Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%). Pneumonia which required hospitalisation occurred in 1% of patients receiving Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) and <1% of patients receiving budesonide/formoterol up to 24 weeks. One fatal case of pneumonia was reported in a patient who received Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta). In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in the Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) and budesonide/formoterol arms was equal at 2%. In a 52-week study, a total of 10,355 patients with COPD with a history of 1 or more moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% for Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) (n = 4,151), 7% for fluticasone furoate/vilanterol (n = 4,134), and 5% for umeclidinium/vilanterol (n = 2,070). Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patient-years) receiving Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta), 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
The incidence of pneumonia events with Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) is comparable with that observed with fluticasone furoate/vilanterol 100/25 in clinical studies in COPD. (See Table 5.)
Click on icon to see table/diagram/image
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