Results from Novartis’ FLASH clinical trial show that switching patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) from treatment with Seretide to Ultibro Breezhaler improved lung function. Ultibro Breezhaler was also found to be well-tolerated by patients.
Seretide is an inhaled corticosteroid, and its long-term use can be associated with several side effects.
In the Phase 4 FLASH trial (NCT02516592), researchers assessed the effects of switching COPD patients from treatment with 50/500 mcg of Seretide (salmeterol/fluticasone), twice daily, to treatment with 110/50 mcg Ultibro Breezhaler (indacaterol/glycopyrronium bromide), taken once daily.
Ultibro Breezhaler is a dual bronchodilator that has been shown in prior clinical studies to be more effective in reducing pulmonary exacerbations than Seretide and open-label Spiriva (tiotropium). The therapy is currently approved in 90 countries as a maintenance bronchodilator treatment to relieve symptoms.
The FLASH trial is the first study to confirm the benefits of directly switching patients from Seretide to Ultibro Breezhaler. The findings are even more significant as patients were switched without a washout period (this is a period of time between different treatments), which mimics normal clinical practice.
“It has already been established that Ultibro Breezhaler improves patients’ lung function when directly compared to Seretide in clinical trials,” Shreeram Aradhye, chief medical officer and global head of medical affairs for Novartis, said in a press release.
“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,” Aradhye added.
The data released also indicates that the safety and tolerability of the two treatments are similar, further supporting the switch to Ultibro Breezhaler.
These results support the latest GOLD recommendations, which endorse the use of dual bronchodilation for most symptomatic COPD patients and limit the use of steroid-based therapies to some patient types.
“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,” Aradhye noted.
The trial results were recently presented at the Asian Pacific Society of Respirology (APSR) Congress held Nov. 23-26 in Sydney, Australia.
Novartis is a biopharmaceutical company with several COPD therapies in its portfolio, including Ultibro Breezhaler, Seebri Breezhaler (glycopyrronium bromide) and Onbrez Breezhaler (indacaterol), all of which are indicated as maintenance treatments for patients with COPD.