Final results from FLAME study confirms superiority of Ultibro® Breezhaler® ▼(indacaterol/glycopyrronium) over Seretide® Accuhaler (salmeterol/fluticasone) for reducing COPD exacerbations1
Ultibro® Breezhaler® (indacaterol/glycopyrronium) is the only once-daily dual bronchodilator which has demonstrated superiority to salmeterol/fluticasone in reducing COPD exacerbations1
Pfizer Ltd, Walton Oaks, UK – Monday 16th April 2016: Presented yesterday at the American Thoracic Society (ATS) congress 2016 in San Francisco and simultaneously published in the New England Journal of Medicine, the FLAME study conducted in 43 countries in over 3,000 patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations set out to demonstrate that once daily indacaterol/glycopyrronium 110/50 µg was at least non inferior to twice daily salmeterol/fluticasone 50/500 µg in reducing the rate of all exacerbations: mild, moderate and severe.
In fact indacaterol/glycopyrronium demonstrated not only non-inferiority but also superiority to salmeterol/fluticasone with a significant 11% reduction in the annual rate of all exacerbations (p=0.003). There was also a significant 17% reduction in the annual rate of moderate or severe exacerbations in favour of indacaterol/glycopyrronium (p < 0.001). The incidence of pneumonia was significantly lower in patients taking indacaterol/glycopyrronium (3.2%) than in patients taking salmeterol/fluticasone (4.8%), p=0.02.1
“The FLAME study results further support the growing body of evidence that indacaterol/glycopyrronium is more effective than salmeterol/fluticasone in reducing exacerbations for patients living with COPD, often such a debilitating condition,” said FLAME study investigator Wisia Wedzicha, Professor of Respiratory Medicine at the National Heart and Lung Institute, Imperial College, UK. “These findings also confirm our need to reassess the widespread use of inhaled corticosteroids and consider steroid-free treatment alternatives for both our exacerbating and non-exacerbating patients” added Professor Wedzicha.
The FLAME study is the first large-scale, head-to-head trial to examine the rate of COPD exacerbations in patients treated with either once-daily indacaterol/glycopyrronium or twice daily salmeterol/fluticasone. Indacaterol/glycopyrronium is a once-daily long-acting beta-2 adrenergic agonist / long-acting muscarinic antagonist (LABA/LAMA) dual bronchodilator combination, with different mechanisms and sites of actions, approved in the EU as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.2
Pfizer UK is in partnership with Novartis to market indacaterol/glycopyrronium in the UK to support the treatment of patients with COPD.
Despite significant ongoing efforts, COPD is a disease that affects an estimated 3 million people across the UK in growing numbers.3,4 It is the fifth leading cause of death, claiming more lives than breast, bowel or prostate cancer.5 Patients with the disease can be helped with treatment, but unfortunately many patients still struggle to control their symptoms.6 Exacerbations of symptoms can have the largest impact on patients’ lives, leading to physical and psychological deterioration, potential repeated hospitalisations, and increased mortality.7,8
Dr Berkeley Phillips, UK Medical Director, Pfizer, commented, “In the largest ever head-to-head trial of a LABA/LAMA combination vs a LABA/inhaled steroid combination with its primary focus on COPD exacerbation control, indacaterol/glycopyrronium was superior to salmeterol/fluticasone in reducing all and moderate to severe exacerbations. FLAME is a landmark trial with the potential to transform national and international guidelines for patients with COPD and a history of exacerbations and could lead to a paradigm shift in how patients with this devastating disease are treated.”
FLAME was a randomised, double-blind, parallel-group, non-inferiority, active-controlled 52- week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries. The primary objective of the study was to demonstrate that indacaterol/glycopyrronium was non-inferior to salmeterol/fluticasone in terms of rate of all COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment, in patients with a history of exacerbation in the previous year.
Secondary endpoints for the study included superiority in terms of rate of all COPD exacerbations over the study duration and efficacy in terms of the following: time to first COPD exacerbation (mild/moderate/severe); rate and time to first moderate-to-severe COPD exacerbation; lung function (trough FEV1); health-related quality of life (as measured by the shortened version of the St George's Respiratory Questionnaire [SGRQ-C]); rescue medication use and safety.
FLAME is the last of 11 studies in the IGNITE Phase III clinical trial programme exploring indacaterol/glycopyrronium for the treatment of COPD.
About IGNITE clinical trial programme
IGNITE is one of the largest international clinical trial programmes in COPD comprising of eleven studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN, FLAME) with more than 10,000 patients across 52 countries. The studies were designed to investigate the efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life in patients treated with indacaterol/glycopyrronium.9
To view the full adverse event profile for indacaterol/glycopyrronium the SPC can be accessed using the following link: https://www.medicines.org.uk/emc/medicine/29533
Pfizer UK Press Office
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1 Wedzicha J et al. Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD. The New England Journal of Medicine 2016;DOI:10.1056/NEJMoa1516385
2 Ultibro® Breezhaler® (indacaterol/glycopyrronium) SPC. Available at: https://www.medicines.org.uk/emc/medicine/29533. Updated 26th October, 2015
3 NHS Medical Directorate (2012) COPD Commissioning Toolkit. London: NHS Medical Directorate
4 Patalano F et al. Addressing unmet needs in the treatment of COPD. European Respiratory Review 2014;23:333–344
5 British Lung Foundation (2007) Invisible Lives Chronic Obstructive Pulmonary Disease (COPD) - finding the missing millions. London: British Lung Foundation
6 Miravitlles M et al. Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study. Respiratory Research 2014;15:122
7 Wedzicha JA et al. Exacerbations of Chronic Obstructive Pulmonary Disease. Respiratory Care 2003;48(12):1204 –1210
8 Donaldson G et al. Increased Risk of Myocardial Infarction and Stroke Following Exacerbation of COPD. CHEST 2010;137:1091–1097
9 Novartis data on file
Date of preparation: May 2016