Abstract

The use of long-acting bronchodilators is central to the chronic obstructive pulmonary disease (COPD) therapy. One of the goals of bronchodilation is to reduce the morning COPD symptoms that are associated with a more severe disease and an increased risk of exacerbations.The aim of the study was to evaluate the clinical efficacy of switching COPD patients with severe morning symptoms who received combinations of long-acting bronchodilators QD to a fixed-dose combination of aclidinium bromide (AB) and formoterol fumarate (FF) BID.Methods. We examined COPD patients treated with combinations of long-acting β2-agonists and M-anticholinergics (but not AB and FF), who continued to complain of severe symptoms in the morning despite the treatment. After examination, the patients were switched to the fixed-dose combination of AB 0.4 mg and FF 0.012 mg (AB/FF) BID in the form of a metered-dose powder inhaler. The patients were examined at baseline and at 6-month follow-up.Results. Of the 115 included COPD patients, 90 completed the study. After 6 months of treatment, they showed a significant decrease in the intensity of cough, sputum amount, severity of distant wheezing, and shortness of breath in the morning (–0.88, –0.38, –0.29, –0.58 on a 4-point scale, the mean score –0.44; p < 0.001). The result of the COPD Assessment test decreased from 28 (24; 34) to 24 (20; 28) (p = 0.011), the distance of a 6-minute walk increased from 319 ± 72 to 354 ± 67 m (p < 0.001). The fixed-dose combination of AB/FF did not cause serious adverse events.Conclusion. The fixed-dose AB/FF combination in COPD patients resulted in a significant clinical improvement and was well tolerated. The AB/FF combination with twice daily dosing regimen is advisable for the patients with morning symptoms persisting despite therapy with other combinations of long-acting bronchodilators with once daily dosing regimen.

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