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Help reduce the impact that COPD exacerbations have on your patients1-5
Even a single exacerbation can lead to poorer outcomes1-3
TRELEGY Ellipta: statistically superior reduction in annual rate of moderate/severe exacerbations vs. budesonide/formoterol4
TRELEGY Ellipta is the only Triple Therapy to provide statistically superior reduction in hospitalised exacerbations vs. a LAMA/LABA (UMEC/VI)5
Statistically superior reduction in annual rate of moderate/severe exacerbations vs. budesonide/formoterol4
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. 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
Statistically superior reduction in annual rate of hospitalised exacerbations vs. a LAMA/LABA (UMEC/VI)5
Adapted from Lipson et al. 20185
Co-primary endpoints of annual rate of on-treatment moderate/severe exacerbations for TRELEGY Ellipta vs. both FF/VI and UMEC/VI were met
Key trial design
-
FULFIL study design⁴
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. budesonide/formoterol, with an extension to 52 weeks in a subset of patients.4
Co-primary endpoints:
- Change from baseline in trough FEV1 and SGRQ score at Week 24
Secondary endpoints include:
- Annual rate of moderate/severe COPD exacerbations
- Change from baseline CAT score
Key exclusion criteria:
- Current diagnosis of asthma causing patient symptoms
- Unresolved pneumonia or severe COPD exacerbation
*A moderate exacerbation was defined as having worsening symptoms of COPD that required treatment with oral/systemic corticosteroids and/or antibiotics. A severe exacerbation was defined as worsening symptoms of COPD that required treatment with inpatient hospitalisation
-
IMPACT trial design⁵
IMPACT is the first trial to assess, over 52 weeks, the efficacy and safety of the single-inhaler triple therapy TRELEGY Ellipta (FF/UMEC/VI) vs. an ICS/LABA (FF/VI) and vs. a LAMA/LABA (UMEC/VI), in symptomatic patients on COPD maintenance treatments who had experienced at least one exacerbation in the last 12 months.5
Primary endpoints:
- Annual rate of on-treatment moderate/severe exacerbations* for TRELEGY Ellipta vs. both comparators
Secondary endpoints include:
- Lung function: change from baseline in trough FEV1 at Week 52
- Health-related quality of life: change from baseline in SGRQ score at Week 52
Other endpoints include
- On-treatment all-cause mortality
Key inclusion criteria:
- Patients aged 40 years or older with COPD and a CAT score ≥10 with:
- FEV1 <50% predicted and ≥1 moderate/severe exacerbation in
the previous year, or - FEV1 ≥50% to <80% predicted and ≥2 moderate exacerbations or ≥1 severe exacerbation in the previous year
- FEV1 <50% predicted and ≥1 moderate/severe exacerbation in
- Patients were required to be receiving daily maintenance therapy for COPD
for at least 3 months prior to screening
Key exclusion criteria:
- Current diagnosis of asthma or other respiratory disorders
- Unresolved pneumonia or COPD exacerbation, or respiratory tract infection ≤14 days or 7 days, respectively
- Oral/systemic corticosteroid use ≤30 days prior to screening
*A moderate exacerbation was defined as an exacerbation leading to treatment with antibiotics or systemic glucocorticoids. A severe exacerbation was one resulting in hospitalisation or death
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Footnotes
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 ICS and a LABA, or a combination of a LAMA and a LABA6
References
- Celli B et al. Am J Respir Crit Care Med 2008; 178:332–338.
- Donaldson GC et al. Chest 2010; 137:1091–1097.
- Soler-Cataluna JJ et al. Thorax 2005; 60:925–931.
- Lipson DA et al. Am J Crit Care Med 2017; 196:438–446.
- Lipson DA et al. N Engl J Med 2018; 378:1671–1680.
- TRELEGY Ellipta SmPC, 2022. Available at www.medicines.ie. Accessed December 2022.
Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie . Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.
Trelegy is a registered trademark of the GlaxoSmithKline group of companies.
TRELEGY Ellipta was developed in collaboration with
Last Updated: December 2022 PM-IE-FVU-WCNT-220022
