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IMPACT was the first Phase III, randomised, double-blind, parallel-group, multicentre, 52-week trial to assess the efficacy and safety of the single-inhaler Triple Therapy TRELEGY Ellipta vs. an ICS/LABA (FF/VI 92/22 mcg) and vs. a LAMA/LABA (UMEC/VI 55/22 mcg) in symptomatic patients on COPD maintenance treatments who had experienced at least one exacerbation in the last 12 months. 1 5
Primary endpoint 1
Annual rate of on-treatment moderate/severe COPD exacerbations for TRELEGY Ellipta vs. both comparators.
Other key endpoints 4
- Lung function: change from baseline in trough FEV1 at Week 52 4
- Health-related quality of life: change from baseline in SGRQ score at Week 52 4
Key inclusion criteria 1 5
Patients aged 40 years or older with COPD and a CAT score ≥10 with:
- FEV1 <50% predicted and >1 moderate/severe exacerbations in the previous year, or
- FEV1 ≥50% to <80% predicted and ≥2 moderate exacerbation or ≥1 severe exacerbation in the previous year
- Patients were required to be receiving daily maintenance therapy for COPD for at least 3 months prior to screening
Key exclusion criteria 1 5
Patients were excluded if they had an of the following:
- a current diagnosis of asthma or other respiratory disorders
- pneumonia or other respiratory tract infection unresolved ≤14 days or ≤7 days, respectively, prior to screening
- unresolved exacerbation ≤14 days prior to screening
- oral/systemic corticosteroid use ≤30 days prior to screening
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The efficacy and safety of TRELEGY Ellipta OD were compared in the FULFIL study with budesonide/formoterol (320/9 mcg) BD. 3
The FULFIL study was a Phase III, randomised, double-blind, double-dummy, parallel-group, multicentre, 24-week study. Patients underwent a 2-week run-in period, during which medications at screening were unchanged from their pre-study COPD maintenance therapy, followed by a 24-week treatment period. 3
A subset of 430 patients (TRELEGY Ellipta OD n=210, BUD/FOR (320/9 mcg) BD n=220) remained on blinded study treatment for up to 52 weeks (the EXT population). Efficacy endpoints and safety were assessed up to Week 52 in the EXT population. 3
Co-primary endpoints 3
- Change from baseline in trough FEV1 and SGRQ score at Week 24
Some secondary/other endpoints 3
- Annual rate of moderate/severe COPD exacerbations
- Change from baseline CAT score
Key inclusion criteria 3
- Patients with COPD with FEV1 <50% and CAT score ≥10, or
- Patients with FEV1 ≥50% to <80% and CAT score ≥10, and either ≥2 moderate exacerbations in the past year or ≥1 severe exacerbation in the past year
- Aged ≥40 years old
Key exclusion criteria 3
- Current diagnosis of asthma causing patient symptoms
- Unresolved pneumonia or severe COPD exacerbation
Abbreviations:
BD, twice-daily; BUD, budesonide; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; EXT, extension; FEV1, forced expiratory volume in one second; FF, fluticasone furoate; FOR, formoterol; ICS, inhaled corticosteroid; LABA, long-acting ß2-agonist; LAMA, long-acting muscarinic antagonist; OD, once-daily; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol.
References:
- Lipson DA et al. N Engl J Med 2018; 378:1671–1680.
- GSK Data On File. RF/TLY/0067/18 IMPACT Study trough FEV1 data over 52 weeks.
- Lipson DA et al. Am J Respir Crit Care Med 2017; 196(4):438–446.
- Lipson DA et al. N Engl J Med 2018; 378:1671–1680 (supplementary material).
- Lipson DA et al. N Engl J Med 2018; 378:1671–1680 (supplementary material protocol).
- TRELEGY Ellipta SmPC, 2020. Available at www.medicines.ie. Accessed January 2020.
- Relvar Ellipta (fluticasone furoate/vilanterol 92/22 mcg) SmPC, 2020. Available at www.medicines.ie [Accessed January 2020].
- Anoro Ellipta (umeclidinium/vilanterol 55/22 mcg) SmPC, 2020. Available at www.medicines.ie [Accessed January 2020].
Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
© 2020 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.
TRELEGY Ellipta OD is indicated for maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an ICS and a LABA, or a combination of a LAMA and a LABA 6
Relvar Ellipta (fluticasone furoate/vilanterol 92/22 mcg) is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy 7
Anoro Ellipta (umeclidinium/vilanterol 55/22 mcg) is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD 8
