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Trelegy Ellipta and health-related quality of life (HRQoL)
Single-inhaler Triple Therapy could help your COPD patients breathe better from today1,2
COPD can make activities such as attending social events with friends or playing with their grandchildren more difficult, impacting quality of life3
TRELEGY Ellipta: Statistically superior improvement vs. budesonide/formoterol in HRQoL1
TRELEGY Ellipta: Statistically superior improvement vs. a LAMA/LABA (UMEC/VI) in HRQoL2
Statistically superior improvement in HRQoL vs. budesonide/formoterol1
Adapted from Lipson et al. 20171
HRQoL determined according to the St. George's Respiratory Questionnaire (SGRQ). Find out more lower down this page. SGRQ MCID=4.0 unit change
The figures have been rounded from -6.57 and -4.33, respectively
Data from the FULFIL study comparing TRELEGY Ellipta OD to BUD/FOR.1 Co-primary endpoints of change from baseline in trough FEV1 and SGRQ score at Week 24 were both met
Statistically superior improvement in HRQoL vs. a LAMA/LABA (UMEC/VI)2
Adapted from Lipson et al. 20182
HRQoL determined according to the St. George's Respiratory Questionnaire (SGRQ). Find out more lower down this page. SGRQ MCID=4.0 unit change
Data from the IMPACT trial comparing TRELEGY Ellipta OD to an ICS/LABA (FF/VI) and a LAMA/LABA (UMEC/VI).2 Co-primary endpoints of annual rate of on-treatment moderate/severe exacerbations for TRELEGY Ellipta vs. both comparators were met. Change from baseline in SGRQ score at Week 52 was a secondary endpoint
Key trial design
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FULFIL study design¹
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.1
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 inclusion criteria
- Patients with COPD with a FEV1 <50% and a CAT score ≥10, or
- Patients with a FEV1 ≥50% to <80% and a CAT score ≥10, and either ≥2 moderate exacerbations in the past year or ≥1 severe exacerbation in the past year*
- Aged ≥40 years
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
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IMPACT trial design²
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.2
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 the previous year, or
- 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; HRQoL, health-related quality of life; ICS, inhaled corticosteroid; LABA, long- acting ß2-agonist; LAMA, long-acting muscarinic antagonist; LS, least squares; MCID, minimal clinically important difference; OD, once daily; 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 LABA4
References
- 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.
- Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD). 2023.
- TRELEGY Ellipta SmPC, 2023. Available at www.medicines.ie. Accessed March 2023.
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: March 2023 PM-IE-FVU-WCNT-220018
