Lung function of COPD patients improved with Ultibro Breezhaler

Novartis has announced positive results from the FLASH study examining the safety and efficacy of directly switching chronic obstructive pulmonary disease (COPD) patients from Seretide (salmeterol/fluticasone) 50/500 mcg to Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg.¹ 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 function^2,3 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 bronchodilator,¹, therefore, avoiding the side effects of the long-term use of inhaled corticosteroids. Importantly, patients were switched without a wash-out period to mimic clinical practice.¹

“It has already been established that Ultibro Breezhaler improves patients’ lung function when directly compared to Seretide in clinical trials,” said Shreeram Aradhye, Chief Medical Officer and Global Head of Medical Affairs for Novartis Pharmaceuticals. “This new research is important because it shows that this benefit also exists when directly switching patients from Seretide to Ultibro Breezhaler as would happen in everyday clinical practice. The FLASH study provides further evidence that it is possible to reduce the burden of long-term inhaled steroids in many COPD patients, as recommended by global treatment guidelines”.

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 types.⁵

Importantly, the data released today also indicated that the safety and tolerability profiles of the two treatments were similar.¹

The FLASH study results were presented at the Asian Pacific Society of Respirology (APSR) Congress in Sydney, Australia (23-26 November 2017).

About the FLASH study

The FLASH study is a randomised, multicenter, double-blind, double-dummy, parallel-group, 12-week treatment trial.¹ It involved a total of 502 moderate-to-severe symptomatic and non-frequently exacerbating chronic obstructive pulmonary disease (COPD) patients.¹

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 on[6]:

• 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

UltibroBreezhaler 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 COPD.⁷ 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.

References

[1]    Frith P, Ashmawi S, Krishnamurthy S, et al. Assessing direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in moderate to severe symptomatic COPD patients: the FLASH study. [APSR 2017 abstract]

[2]    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

[3]    Zhong N, Wang C, Zhou X, et al. LANTERN: a randomised study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:1015-1026

[4]    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

[5]    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].

[6]    ClinicalTrials.gov. Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort (FLASH). Available at: https://clinicaltrials.gov/ct2/show/NCT02516592?term=indacaterol%2
Fglycopyrronium&cond=Copd&outc=fev1&spons=novartis&draw=1&rank=3 [Accessed 16 October 2017]

[7]    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].

[8]    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].

[9]    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].

[10]  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].