Video - IMPACT Trial Explained
Determining the patient benefit that could be achieved by adding an inhaled corticosteroid to dual bronchodilator therapy.
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Watch the short video below to hear from Professor David Halpin who will provide an overview of:
Other NMAs exist which differ in their methodology and study inclusion which do not show any statistical differences between SITTs. No head-to-head randomised control clinical trials exist for single inhaler triple therapies.
Difference in improvement in lung function for Trelegy vs. other COPD single inhaler triple therapies
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
Secondary endpoints include:
Key inclusion criteria
Key exclusion criteria:
Trelegy Ellipta Prescribing Information
Seretide Accuhaler 50/500 (salmeterol/fluticasone propionate) Prescribing Information
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.3
Seretide (50 micrograms salmeterol and 500 micrograms fluticasone propionate) is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
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
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.
March 2023 | PM-GB-FVU-WCNT-200015 (V6.0)