In a phase 4 trial, combination salmeterol/fluticasone produced similar relief from COPD as indacaterol.
Patients with chronic obstructive pulmonary disease (COPD) experienced similar lung function after receiving once-daily indacaterol as compared to twice-daily combination salmeterol/fluticasone propionate (SFC) 50/500 mcg, drug maker Novartis announced.
In the phase 4 INSTEAD study, researchers studied 581 COPD patients who had been taking SFC for at least 3 months and had no exacerbations in the previous year. Participants were randomized to continue taking SFC or switch to once-daily Onbrez Breezhaler (indacaterol) 150 mcg.
The researchers examined non-inferiority of indacaterol versus SFC in lung function after 12 weeks. After 12 and 26 weeks, patients in both study arms showed similar symptomatic benefits, including shortness of breath and health status. Full results of the study are expected to be presented at major medical conferences later this year.
“These positive results help inform the switch from SFC to indacaterol in patients with moderate COPD and who are at low risk of exacerbations,” Tim Wright, Global Head of Development at Novartis Pharmaceuticals, said in a press release. “This confirms that indacaterol provides an effective maintenance treatment option for these patients. In addition, these results support international guidelines, which advise against the use of inhaled corticosteroids due to long-term risks in COPD patients at low risk of exacerbations.”
In a previous phase 3 trial, inhaled indacaterol provided reduced shortness of breath, less use of rescue medication, and improved health status compared to tiotropium. The drug is currently available in Japan, the United States, and 100 other countries.