In the landmark IMPACT trial, TRELEGY Ellipta reduced the annual rate of moderate/severe exacerbations vs. FF/VI at 52 weeks 1
In the landmark IMPACT trial, TRELEGY Ellipta reduced the annual rate of moderate/severe exacerbations vs. UMEC/VI 1
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 4
Primary endpoint 1
Annual rate of on-treatment moderate/severe COPD exacerbations for TRELEGY Ellipta vs. both comparators.
Other key endpoints 1
- Lung function: change from baseline in trough FEV1 at Week 52 1, 3
- Health-related quality of life: change from baseline in SGRQ score at Week 52 1, 3
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
Patients were excluded if they had any 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
The efficacy and safety of TRELEGY Ellipta OD was compared in the FULFIL study with budesonide/formoterol (BUD/FOR, 320/9 mcg BD).2
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.2
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.2
- Change from baseline in trough FEV1 and SGRQ score at Week 24
Some secondary/other endpoints2
- Annual rate of moderate/severe COPD exacerbations
- Change from baseline CAT score
Key inclusion criteria2
- 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 criteria2
- Current diagnosis of asthma causing patient symptoms
- Unresolved pneumonia or severe COPD exacerbation
Moderate exacerbation was an exacerbation that required antibiotics or systemic gluticoricoids. Severe exacerbation was an exacerbation that led to hospitalisation or death
More efficacy data:
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; NNT, number needed to treat; OD, once-daily; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol.
- Lipson DA et al. N Engl J Med 2018; 378:1671–1680.
- 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 2018, Available at www.medicines.ie [Accessed January 2020]
- Relvar Ellipta (fluticasone furoate/vilanterol 92/22 mcg) SmPC, 2018. Available at www.medicines.ie [Accessed January 2020]
- Anoro▼ Ellipta (umeclidinium/vilanterol 55/22 mcg) SmPC, 2018. Available at www.medicines.ie [Accessed January 2020]
TRELEGY Ellipta, Relvar Ellipta and Anoro Ellipta were developed in collaboration with INNOVIVA Inc.