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Video - IMPACT Trial Explained
Determining the patient benefit that could be achieved by adding an inhaled corticosteroid to dual bronchodilator therapy.
Over one year of maintenance therapy, 52% of COPD patients continue to suffer from ongoing breathlessness*¹. How could Trelegy Ellipta help?
Trelegy Ellipta delivered superior improvement in lung function vs an ICS/LABA²
Adapted from Lipson et al. 2017²
Data from the FULFIL study comparing Trelegy Ellipta OD to Symbicort Turbohaler BD (BUD/FOR).²
Co-primary endpoints of change from baseline in trough FEV₁ and SGRQ score at Week 24 were both met. Further information on the FULFIL study lower down this page.
*MCID: Minimal Clinically Important Difference. Patients with COPD have been shown to perceive an improvement of ≥100mL in trough FEV₁ as beneficial.³
See more Trelegy Ellipta clinical data
Key trial design
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FULFIL study design²
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.²
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
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.⁴
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.⁴
In common with other corticosteroid-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Trelegy Ellipta.⁴
*Retrospective longitudinal analysis of data from the Swedish National Register of COPD. Prevalence of breathlessness (mMRC ≥2) after median follow-up of 12 months in COPD patients receiving treatment (LABA, LAMA and/or ICS) (N=1475).¹
References
- Sundh J, et al Int J Chron Obstruct Pulmon Dis. 2016;11:2805–2812
- Lipson DA et al. Am J Crit Care Med 2017; 196:438–446.
- Jones PW et al. Am J Respir Crit Care Med 2014; 189(3):250–255.
- 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.
© 2020 GSK Group of Companies or its licensor
Trademarks are the property of their respective owners
Trelegy Ellipta was developed in collaboration with
PM-GB-FVU-WCNT-200015 | October 2020
