WILMINGTON, DE — AstraZeneca (NYSE: AZN) said full results from the Phase III KALOS and LOGOS trials, published in The Lancet Respiratory Medicine, showed its triple-combination inhaler BREZTRI Aerosphere significantly improved lung function and reduced severe exacerbations in patients with uncontrolled asthma compared with dual-combination therapies.
In a pooled analysis of the two trials, BREZTRI improved morning pre-dose trough FEV1 by 76 mL over 24 weeks and FEV1 area under the curve from zero to three hours by 90 mL, compared with inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) treatments combined, according to the published data.
The results were statistically significant, with p-values less than 0.001.
The pooled analysis also found clinically meaningful reductions in the annualized rate of severe asthma exacerbations versus ICS/LABA therapies in patients with or without a recent exacerbation.
The KALOS and LOGOS trials enrolled about 4,300 randomized patients and evaluated two doses of budesonide/glycopyrronium/formoterol fumarate, delivered via a pressurized metered-dose inhaler. The primary endpoints included changes in forced expiratory volume in one second, or FEV1, over 24 weeks.
“Many of the 262 million people worldwide living with asthma remain uncontrolled and still struggle with symptoms like frequent breathlessness, coughing and wheezing despite the use of dual maintenance therapy,” said Alberto Papi, professor and chair of respiratory medicine at the University of Ferrara and primary investigator. He said the trials showed the triple therapy “improved lung function, and, importantly, prevented future severe exacerbations in patients, regardless of exacerbation history.”
Sharon Barr, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said the company hopes to make BREZTRI available for patients with uncontrolled asthma, building on its existing use in chronic obstructive pulmonary disease, or COPD.
There were no new safety or tolerability signals identified in the KALOS or LOGOS trials, the company said.
BREZTRI is approved for the maintenance treatment of adults with COPD in more than 80 countries, including the United States, the European Union, China and Japan. Regulatory filings for asthma are under review in major regions, according to AstraZeneca.
The prescribing information states BREZTRI is not indicated for the treatment of asthma or the relief of acute bronchospasm and is not a rescue inhaler. The most common adverse reactions reported in clinical trials included upper respiratory tract infection, pneumonia, back pain and oral candidiasis.
Full trial results are available in The Lancet Respiratory Medicine.
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