(RxWiki News) Two main traits of chronic obstructive pulmonary disease (COPD) are a restricted airway and limited airflow to the lungs. While COPD is not reversible, medications can help patients breathe better.
They found that the experimental medication opened up patients' airways and increased the amount of air patients could blow out — two key measures of COPD symptoms.
The measure of airway opening seen in patients treated with this experimental medication was comparable to that seen in patients treated with formoterol.
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This study was conducted by Piotr Kuna, MD, of the Medical University of Lodz in Poland, and colleagues from institutions in Bulgaria, Russia, Japan, Sweden and Canada.
The researchers tested the effectiveness and safety of AZD3199, a new type of inhaled ultra long-acting beta-agonist (LABA). LABAs are medications that cause the muscles around the bronchial tubes to relax, allowing the airways to widen.
The main aim of the study was to see which dose of this experimental medication would maintain 24-hour bronchodilation (opening bronchial air passages) in patients with COPD.
The study included 329 patients who were randomly assigned to take 200, 400 or 800 µg of AZD3199, 9 µg of formoterol or a placebo. All of these medications, including the placebo, were delivered by inhaler.
Participants were treated for four weeks. After four weeks, the researchers measured participants' forced expiratory volume in one second (FEV1), or the amount of air that can be forcefully blown out of the lungs in one second.
Compared to placebo, all doses of AZD3199 had increased mean peak and trough FEV1 values. Peak FEV1 increased by 106–171 ml with AZD3199 treatment compared with placebo, while trough FEV1 increased by 97–110 ml (statistically significant at all dose levels).
The researchers did not find any clear dose-response, meaning it did not matter which dose of AZD3199 patients received. This finding suggests that 200 µg or less may be enough for patients to maintain open airways.
The researchers also found that patients who took AZD3199 had reduced COPD symptoms and reliever use. Reliever medications, such as salbutamol, are used to control exacerbations of COPD.
The rates of negative side effects were "...generally low and similar between study groups," the authors wrote, and most of these side effects were mild.
"All of the AZD3199 doses produced 24-hour bronchodilation, but with no clear dose-response, suggesting that doses of 200 µg or less may be sufficient to maintain bronchodilation over 24 hours in patients with COPD," the authors concluded.
"No safety concerns were identified. Further studies are required to determine the appropriate once-daily AZD3199 dose for COPD," they wrote.
This study, which was the first to assess the safety and effectiveness of AZD3199 in COPD patients, was published June 3 in Respiratory Research.