Registration successful.
Account activated – Pending validation
Your account has been activated successfully, but we still need to validate you as a UK healthcare professional. We’ll send you an email with the result. Please note this could take up to 10 days.
In the meantime, you can enjoy access to all the latest news, events and resources on our website.
Video - IMPACT Trial Explained
Determining the patient benefit that could be achieved by adding an inhaled corticosteroid to dual bronchodilator therapy.
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 further 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.
Doses shown as delivered doses, equating to a pre-dispensed dose of: FF/UMEC/VI 100/62.5/25 and BUD/FOR 400/12
See more Trelegy Ellipta clinical data
Key trial design
-
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
Prescribing Information Links
Trelegy Ellipta Prescribing Information (pdf)
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.1
Footnotes
BD, twice daily; CAT, COPD assessment test; FEV1, forced expiratory volume in one second; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; SGRQ, St George’s Respiratory Questionnaire
References
- Trelegy Ellipta SmPC
- Lipson DA et al. Am J Crit Care Med 2017; 196:438-446.
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.
© 2021 GSK Group of Companies or its licensor
Trademarks are the property of their respective owners
Trelegy Ellipta was developed in collaboration with
November 2021 | PM-GB-FVU-WCNT-200015 (V3.0)
