A positive batch of late-stage trial data has put Spanish drug manufacturer Almirall and US group Forest Laboratories one step closer to improving COPD wellness. The company has announced the results of their study, which indicates they are close to filling their chronic obstructive pulmonary disease (COPD) inhaler Genuair with regulators which could greatly improve COPD sufferers’ wellbeing.
Genuair delivers a fixed dose of alclidinium bromide and formoterol fumarate, which are two different bronchodilators with different modes of action. The doses of aclidinium/formoterol tested were 400/6mcg and 400/12mcg, taken twice a day. According to the group, both of the bronchodilators made their primary endpoints during the pivotal six-month Phase III clinical trial of Genuair (also known as Pressair).
The study researchers boasted that both doses of the aclidinium/formoterol combination showed statistically significant improvements in lung function. This was measured by change from baseline in morning pre-dose through FEV1, and compared with formoterol 12mcg and in FEV1 at one hour post-dose versus aclidinium 400mcg. The study researchers also noted that both treatment arms were well tolerated in the study, although nasopharyngitis and back pain were the most common side effects experienced.
A second Phase III trial is now underway, the results of which are expected over the coming weeks. If this second trial produces positive results, the groups will have the support they need to file a New Drug Application with regulators on both sides of the pond. According to Bertil Lindmark, Chief Scientific Officer at Almirall, ‘We expect this novel combination of aclidinium/formoterol to offer patients a new option in COPD treatment. In addition to the improved efficacy shown in this study, the safety profile was comparable to placebo.’
The World Health Organisation (WHO) calls COPD as a global epidemic, with an estimated 64 million people suffering from the condition around the world. Chronic obstructive pulmonary disease is common, progressively debilitating your lungs through persistent airflow limitation that makes it hard to breathe. Therefore, a new treatment which could effectively reduce the symptoms of COPD is always welcome, and this study may provide new hope for millions of sufferers worldwide.
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