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
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 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
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
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.
- 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].
TRELEGY Ellipta, Relvar Ellipta and Anoro Ellipta were developed in collaboration with INNOVIVA Inc.