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Watch Professor David Lipson describe the recent mortality data from the IMPACT study.
Help reduce the impact that COPD exacerbations have on your patients 1-5
Even a single exacerbation can lead to poorer outcomes 1-3
TRELEGY Ellipta: superior reduction in annual rate of moderate/severe exacerbations vs. Symbicort Turbuhaler 4
TRELEGY Ellipta is the only Triple Therapy to provide superior reduction in hospitalised exacerbations vs. a LAMA/LABA (UMEC/VI) 5
Superior reduction in annual rate of moderate/severe exacerbations vs. Symbicort Turbuhaler 4
Adapted from Lipson et al. 2017 4
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 Turbuhaler BD (BUD/FOR), with an extension to 52 weeks in a subset of patients 4
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 weeks 4
The co-primary endpoints of change from baseline in trough FEV1 and SGRQ score at Week 24 were both met in this study 4
Key trial design
-
FULFIL study design [4]
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 Turbuhaler BD (BUD/FOR), 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 inclusion criteria
- Patients with COPD with a FEV1 <50% and a SGRQ score at Week 24 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
-
IMPACT trial design [5]
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 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
Helping COPD patient live longer and better.
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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 1
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 local prescribing information based on EMEA v1
© 2020 GSK Group of Companies or its licensor
Trademarks are the property of their respective owners
TRELEGY Ellipta was developed in collaboration with
PM-SA-FVU-WCNT-200009 Date of preparation: September 2020
