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Exacerbations in COPD: What’s the risk?
How does an exacerbation affect patient quality of life and lung function?
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
Trelegy Ellipta is the only single inhaler triple therapy to demonstrate reduction in annual rate of hospitalised exacerbations vs. a LAMA/LABA (UMEC/VI▼)⁵
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 met⁶
Anoro ▼ Ellipta (umeclidinium bromide/vilanterol) is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).⁶
Key trial design
-
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 (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
Relvar (Fluticasone furoate/Vilanterol) prescribing information
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
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 inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.⁷
Trelegy Ellipta is generally well tolerated. Common adverse reactions include: headache, nasopharyngitis, influenza, upper respiratory tract infection, pneumonia, back pain, rhinitis, cough, pharyngitis, arthralgia, sinusitis, oropharyngeal pain, bronchitis, constipation, candidiasis of mouth and throat, urinary tract infection. This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of adverse reactions before prescribing.⁷
In common with other corticosteroid-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Trelegy Ellipta.⁷
Anoro Ellipta (umeclidinium bromide/vilanterol) is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).⁶
*Defined as a worsening of symptoms, or has experienced an exacerbation treated with antibiotics or oral corticosteroid in the past 12 months
†Post hoc analysis of the 3-year Toward a Revolution in COPD Health (TORCH) study in patients with moderate or severe COPD (treatment arms: salmeterol 50 mcg, fluticasone propionate 500 mcg, salmeterol/fluticasone propionate 50/500 mcg or placebo, all twice daily). The primary endpoint of the study did not reach statistical significance. Data shown compares patients with >0-1 moderate /severe exacerbations per annum vs. 0 exacerbations per annum. Analysis includes patients on active treatment and placebo.¹
Seretide (Salmeterol xinafoate/fluticasone propionate) prescribing information
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.
- ANORO Ellipta SmPC.
- TRELEGY Ellipta SmPC.
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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Trademarks are the property of their respective owners
Trelegy Ellipta was developed in collaboration with
PM-GB-FVU-WCNT-200013 | Feb 2021
