27 November 2017
New data showed Ultibro® Breezhaler® significantly improved COPD patients’ lung function after direct switch from Seretide®
New data showed switching moderate-to-severe, symptomatic COPD patients from Seretide®§ to Ultibro® Breezhaler® improved lung function and was well-tolerated.
The FLASH study is the first randomized controlled trial to investigate the direct switch of patients from steroid-containing Seretide® to the dual bronchodilator Ultibro®
Data were presented at the Asian Pacific Society of Respirology (APSR) Congress in Sydney, Australia.
Chippenham, UK – 27 November 2017: Vectura Group plc (LSE: VEC) ("Vectura"), an industry-leading device and formulation business for inhaled airways products, confirms the announcement made today by Novartis of positive results from the FLASH* study. This study examined the safety and efficacy of directly switching moderate-to-severe symptomatic and non-frequently exacerbating† chronic obstructive pulmonary disease (COPD) patients from Seretide® (salmeterol/fluticasone) 50/500 mcg to Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg1.
The study met the primary endpoint, demonstrating that switching patients to Ultibro Breezhaler resulted in significantly improved lung function (trough FEV1)1.
The superiority of once-daily Ultibro Breezhaler over twice-daily salmeterol/fluticasone in improving lung function2-3 and reducing the rate of COPD exacerbations4 has been established in previous studies. The FLASH study is the first randomised controlled trial to confirm the benefits of directly switching patients from this steroid-containing therapy to the dual bronchodilator1, therefore avoiding the side effects of the long-term use of inhaled corticosteroids. Critically, patients were switched without a wash-out period‡ to mimic clinical practice1.
These results further reinforce the latest GOLD recommendations, which support the use of dual bronchodilation for the majority of symptomatic COPD patients and limit the use of steroid-containing therapies to specific patient types5.
Importantly, the data released today also indicated that the safety and tolerability profiles of the two treatments were similar.
The FLASH study results were presented at the Asian Pacific Society of Respirology (APSR) Congress in Sydney, Australia (23-26 November 2017).
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Vectura Group plc
+44 (0)1249 667700
Elizabeth Knowles – Director Investor Relations and Analysis
David Ginivan – VP Corporate Communications
Consilium Strategic Communications
+44 (0)20 3709 5700
Mary-Jane Elliot / Chris Welsh / Jessica Hodgson
Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading device and formulation business for inhaled airways products offering a uniquely integrated inhaled drug delivery platform. With our extensive range of device and formulation technologies, integrated capabilities and collaborations, we are a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases.
Vectura has eight inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams. The Group has a diverse portfolio of drugs in clinical development, including a number of novel and generic programmes which are partnered with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork along with two wholly owned nebulised development programmes.
For further information, please visit Vectura's website at www.vectura.com.
About the FLASH study
The FLASH study is a randomized, multicenter, double-blind, double-dummy, parallel-group, 12-week treatment trial1. It involved a total of 502 moderate-severe, symptomatic and non-frequently exacerbating† patients with COPD1.
The primary objective of the study was to demonstrate the superiority of once-daily Ultibro® Breezhaler® 110/50 mcg compared with twice-daily salmeterol/fluticasone (50/500 mcg) in terms of improving lung function (trough pre-dose FEV1 at Week 12)1.
Secondary objectives of the study were to investigate the effect of Ultibro Breezhaler compared with salmeterol/fluticasone on6:
- Transition Dyspnea Index (TDI) focal score at Week 12
- Trough pre-dose forced expiratory vital capacity (FVC) at Week 12
- COPD symptoms at Week 12 as measured by the COPD Assessment Test (CAT)
- Mean rescue medication use (puffs/day) and percentage of days without rescue medication use over 12 weeks
The study also assessed the safety and tolerability over 12 weeks (including adverse events, serious adverse events and COPD exacerbations)1.
About Ultibro Breezhaler
Ultibro® Breezhaler® 110/50 mcg is a once-daily LABA**/LAMA†† dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD7. Clinical trials have shown that it offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including salmeterol/fluticasone 50/500 mcg and open-label tiotropium (18 mcg)8-10. Ultibro Breezhaler is currently approved for use in over 90 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.
About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler® (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura.
Novartis continues development of respiratory products for delivery via the low resistance Breezhaler inhalation device, which makes it suitable for patients with different severities of airflow limitation11. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly7,11.
Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide12 and is the fourth leading cause of death13. It is progressive (usually gets worse over time) and can be a life-threatening disease5,12. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients’ function (i.e. activity limitation, decreased mobility) and quality of life 5,12.
- Seretide is a registered trademark of the GlaxoSmithKline Group of Companies
* Assessment of switching salmeterol/fluticasone to indacaterol/glycopyrronium in a symptomatic COPD patient cohort
†Patients with a history of up to one exacerbation in the past year
‡ Unlike most clinical trials, Ultibro Breezhaler was started immediately after stopping salmeterol/fluticasone, to mimic clinical practice
** A long-acting beta2-adrenergic agonist
†† A long-acting muscarinic antagonist
- Frith P, Ashmawi C, Krishnamurthy S, et al. Assessing direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in moderate to severe symptomatic COPD patients: The FLASH study. Respirology. 2017; 22 (Suppl. 3): p70 (AOL011)
- Vogelmeier C et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone in patients with COPD (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respiratory Medicine. 2013;1(1):51-60
- Zhong N, Wang C, Zhou X, et al. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:1015-1026
- Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol/Glycopyrronium Versus Salmeterol/Fluticasone for COPD Exacerbations. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385
- Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD, 2017. Available at: http://goldcopd.org [Accessed 16 October 2017].
- ClinicalTrials.gov. Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symptomatic COPD Patient Cohort (FLASH). Available at: https://clinicaltrials.gov/ct2/show/NCT02516592?term=indacaterol%2Fglycopyrronium&cond=Copd&outc=fev1&spons=novartis&draw=1&rank=3 [Accessed 16 October 2017]
- Ultibro Breezhaler EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/WC500151255.pdf [Accessed 16 October 2017].
- Vogelmeier C, et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes versus placebo, indacaterol, glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD. [ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15 -10:45].
- Vogelmeier C, et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS 2013 abstract 851178; Session 82; Date: September 8, 2013 Time: 12:50-14:40].
- Banerji D, et al. Dual bronchodilation with once-daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials. [ERS 2013 abstract 851388; Session 346; Date: September 10, 2013 Time: 8:30-10:30].
- Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO. 2010; 26; 11:2527–2533.
- Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/ [Accessed 16 October 2017].
- World Health Organization: The top 10 causes of death fact sheet No 310. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed 16 October 2017].