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Exacerbations in COPD: What’s the risk?
How does an exacerbation affect patient quality of life and lung function?
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Trelegy vs an ICS/LABA
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
In another double blind, 52 week, randomised control trial Trelegy demonstrated a 13% reduction (non-significant) in hospitalised exacerbations vs an ICS/LABA, (Relvar, fluticasone furoate/vilanterol) (ARR: 0.02, p=0.064)5 -
Trelegy vs a LAMA/LABA
Trelegy Ellipta is the only triple therapy that demonstrated a reduction in hospitalised exacerbations compared with a LAMA/LABA (umeclidinium/vilanterol▼)
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 met5
LAMA/LABAs are indicated as maintenance bronchodilator treatments to relieve symptoms in adult patients with COPD
See more Trelegy Ellipta data
Key trial design
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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. Symbicort Turbohaler 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
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 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 (Fluticasone Furoate/Vilanterol) and vs. a LAMA/LABA (Umeclidinium/Vilanterol ▼), 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. ICS/LABA (FF/VI) and LAMA/LABA (UMEC/VI)
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
COPD Triple Therapy vs. dual bronchodilator therapy - what is the difference for patients?
Watch Professor Paul Jones, GSK Global Medical Expert, give an overview of the IMPACT trial which aimed to determine the patient benefit that could be achieved by adding an inhaled corticosteroid to dual bronchodilator therapy.
Prescribing Information Links
Trelegy Ellipta Prescribing Information (pdf)
Anoro ▼ Ellipta (umeclidinium/vilanterol)
Relvar Ellipta (Fluticasone furoate/vilanterol) prescribing information (pdf)
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
Anoro Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)6
Relvar Ellipta 92/22mcg is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilation therapy3
Footnotes
BD, twice daily; BUD, budesonide; CAT, COPD assessment test; FEV1, forced expiratory volume in one second; FF/UMEC/VI, fluticasone furoate, umeclidinium, vilanterol; FOR, formoterol; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; QoL, quality of life; SGRQ, St George’s Respiratory Questionnaire; ARR, absolute risk reduction
References
- Celli B et al. Am J Respir Crit Care Med 2008; 178:332-338.
- Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2021 pages 30 and 107.
- RELVAR Ellipta SmPC
- 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.
- ANORO Ellipta SmPC.
- TRELEGY Ellipta SmPC.
- IQVIA MIDAS data. Volume (units) since 2017 launch up to January 2021
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
January 2022 | PM-GB-FVU-WCNT-200013 (V5.0)
