- 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 Breezhaler.
- Data presented at the Asian Pacific Society of Respirology (APSR) Congress in Sydney, Australia.
- Novartis today 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. The study met the primary endpoint demonstrating that switching patients to Ultibro Breezhaler resulted in significantly improved lung function (trough FEV1) .
The superiority of once-daily Ultibro Breezhaler over twice-daily salmeterol/fluticasone in improving lung function - and reducing the rate of COPD exacerbations has been established in previous studies. The FLASH study is the first randomized controlled trial to confirm the benefits of directly switching patients from this steroid-containing therapy to the dual bronchodilator , 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.
"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.
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).
About the FLASH study
The FLASH study is a randomized, multicenter, double-blind, double-dummy, parallel-group, 12-week treatment trial. It involved a total of 502 moderate-to-severe symptomatic and non-frequently exacerbating** chronic obstructive pulmonary disease (COPD) patients.
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) .
Secondary objectives of the study were to investigate the effect of Ultibro Breezhaler compared with salmeterol/fluticasone on :
- 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) .
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 COPD. 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) - . 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 limitation. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly , .
Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide and is the fourth leading cause of death. It is progressive (usually gets worse over time) and can be a life-threatening disease , . 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 , .