Results from a Novartis Pharmaceuticals Canada study to assess the company’s Ultibro Breezhaler were published in the New England Journal of Medicine. Researchers say the results are promising and expected to impact the future management and treatment of patients with chronic obstructive pulmonary disease (COPD).
An article describing the findings, “Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD,” was published on June 9, 2016. The study was called FLAME.
Estimates from 2009 and 2010 demonstrate that 4% of Canadians older than 35 are affected by some type of COPD. Cigarette smoking, the leading cause of the condition, is responsible for 80% of COPD-related deaths.
The Phase 3 FLAME clinical trial was a randomized, double-blind, double-dummy, parallel-group, non-inferiority, active-controlled study to evaluate the efficacy of once-daily Ultibro Breezhaler (indacaterol/glycopyrronium bromide) in decreasing COPD exacerbations (flare-ups).
Ultibro Breezhaler 110/50 mcg is a once-daily long acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) dual bronchodilator approved in Canada for the maintenance treatment of airflow obstruction in COPD patients.
The 52-week study involved 3,362 COPD patients and was conducted at 356 sites in 43 countries. The study’s primary outcome was the annual rate of COPD exacerbations.
Selected COPD patients had a history of at least one exacerbation during the previous year. Patients were randomly given either inhaled indacaterol/glycopyrronium bromide 110/50 mcg once-daily (group 1) or inhaled salmeterol/fluticasone 500 mcg twice daily (group 2). Salmeterol is a LABA and fluticasone is a glucocorticoid.
Adverse side effect reported in the FLAME study were similar in the two groups.
Pneumonia was recorded in 3.2% of patients in the indacaterol/glycopyrronium group and in 4.8% of patients in the salmeterol–fluticasone group. The combination indacaterol/glycopyrronium was more effective for preventing COPD exacerbations than salmeterol/fluticasone.
“Preventing exacerbations preserves the health and quality of life of patients struggling with COPD. The FLAME study results greatly improve our understanding of COPD management,” said Dr. Kenneth Chapman, Director of the Asthma and Airway Centre of the University of Health Network, in a press release.
Chapman said the study demonstrated the ability of Ultibro Breezhaler to reduce exacerbations without an inhaled corticosteroid.
“This underscores the importance of the bronchodilator foundation for COPD patients,” Chapman said.
Ultibro Breezhaler has been approved in more than 80 nations worldwide, including Australia, Japan, Latin America, Switzerland and countries within the EU.