PURPOSE:The Almirall inhaler is a new multidose dry powder inhaler used to deliver aclidinium bromide –a novel, long-acting, anticholinergic in Phase III development for the treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the inspiratory flow characteristics through the Almirall inhaler in patients with moderate or severe COPD; these include peak inspiratory flow (PIF), the frequency of successful (activation of the trigger threshold mechanism) and optimal (PIF ≥45 L/min to ensure inhalation of the full dose) inhalations.
METHODS:In this open-label, randomized, three period cross-over, single center study, patients inhaled placebo powder through the Almirall inhaler, HandiHaler® A (slow, deep inhalation as per manufacturer's instructions) or HandiHaler® B (fast, hard inhalation). For each method of administration, three measurements were recorded at 10 minute intervals.
RESULTS:A total of 48 patients with moderate (n=24) or severe (n=24) COPD completed the study. In the overall population, the highest PIF (mean ± standard deviation) generated through the Almirall inhaler (97.7 ± 15.7 L/min) was greater than that generated through HandiHaler® A (51.2 ± 10.4 L/min) and HandiHaler® B (64.3 ± 8.7 L/min). Similarly, average PIF (mean ± standard deviation) was greater for the Almirall inhaler (92.0 ± 15.4 L/min) versus HandiHaler® A (46.1 ± 9.6 L/min) and HandiHaler® B (61.5 ± 8.9 L/min). In total, 97% of inhalations were successful and optimal using the Almirall inhaler. With HandiHaler® A, some powder remained in the inhaler after 21.5% of inhalations (not assessed for HandiHaler® B).
CONCLUSION:The inspiratory airflow generated through the Almirall inhaler by patients with moderate or severe COPD was sufficient to reliably inhale the full dose and reset the device.
CLINICAL IMPLICATIONS:The Almirall inhaler has lower flow resistance than the HandiHaler®, which may benefit patients with COPD, particularly those with low inhalation capacity.
DISCLOSURE:Helgo Magnussen, Employee Esther Garcia Gil - AlmirallRoland Greguletz - AlmirallDiana Jarreta - Almirall; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Aclidinium bromide is a novel, inhaled, once-daily anticholinergic bronchodilator currently in Phase III development for the treatment of patients with chronic obstructive pulmonary disease.