Exacerbations in COPD: What’s the risk?
How does an exacerbation affect patient quality of life and lung function?
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Adapted from Lipson et al. 2017⁴
FULFIL was a Phase III, randomised, double-blind, double-dummy, parallel-group, multicentre, 24-week study designed to assess the efficacy and safety of the single-inhaler Triple Therapy Trelegy Ellipta OD (FF/UMEC/VI) vs. Symbicort Turbohaler BD (BUD/FOR), with an extension to 52 weeks in a subset of patients⁴
The extension population was comprised of a subset of patients in the ITT population (N=1,810) who were enrolled into the 52-week extension phase of the study and remained on blinded treatment for up to 52 weeks⁴
The co-primary endpoints of change from baseline in trough FEV₁ and SGRQ score at Week 24 were both met in this study⁴
Adapted from Lipson et al. 2018⁵
Based on data up to 52 weeks. Co-primary endpoints of annual rate of on-treatment moderate/severe exacerbations for Trelegy Ellipta vs. both FF/VI and UMEC/VI were met⁶
Anoro ▼ Ellipta (umeclidinium bromide/vilanterol) is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).⁶
BD, twice daily; BUD, budesonide; CAT, COPD assessment test; FEV₁, forced expiratory volume in one second; FF, fluticasone furoate; FOR, formoterol; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting ß2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; QoL, quality of life; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol
Trelegy Ellipta OD is indicated for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.⁷
Trelegy Ellipta is generally well tolerated. Common adverse reactions include: headache, nasopharyngitis, influenza, upper respiratory tract infection, pneumonia, back pain, rhinitis, cough, pharyngitis, arthralgia, sinusitis, oropharyngeal pain, bronchitis, constipation, candidiasis of mouth and throat, urinary tract infection. This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of adverse reactions before prescribing.⁷
In common with other corticosteroid-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Trelegy Ellipta.⁷
Anoro Ellipta (umeclidinium bromide/vilanterol) is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).⁶
*Defined as a worsening of symptoms, or has experienced an exacerbation treated with antibiotics or oral corticosteroid in the past 12 months
†Post hoc analysis of the 3-year Toward a Revolution in COPD Health (TORCH) study in patients with moderate or severe COPD (treatment arms: salmeterol 50 mcg, fluticasone propionate 500 mcg, salmeterol/fluticasone propionate 50/500 mcg or placebo, all twice daily). The primary endpoint of the study did not reach statistical significance. Data shown compares patients with >0-1 moderate /severe exacerbations per annum vs. 0 exacerbations per annum. Analysis includes patients on active treatment and placebo.¹
Seretide (Salmeterol xinafoate/fluticasone propionate) prescribing information
References
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.
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Trelegy Ellipta was developed in collaboration with
PM-GB-FVU-WCNT-200013 | Feb 2021