Comparison of peak inspiratory flow rate via the Breezhaler®, Ellipta® and HandiHaler® dry powder inhalers in patients with moderate to very severe COPD: a randomized cross-over trial

The chronic and progressive nature of chronic obstructive pulmonary disease (COPD) requires self-administrationof inhaledmedication. Dry powder inhalers(DPIs) are increasingly being used for inhalationtherapy in COPD. Important considerations when selecting DPIs include inhalationeffort required and flow rates achieved by patients. Here, we present the comparison of the peak inspiratory flow rate (PIF) values achieved by COPD patients, with moderate to very severe airflow limitation, through the Breezhaler®, the Ellipta® and the HandiHaler® inhalers. The effects of disease severity, age and gender on PIF rate were also evaluated. This randomized, open-label, multicenter, cross-over, Phase IV study recruited patients with moderate to very severe airflow limitation (Global Initiative for Obstructive Lung Disease2014 strategy), aged ≥40 years and having a smoking history of ≥10 pack years. No active drug or placebo was administered during the study. The inhalationprofiles were recorded using inhalersfitted with a pressure tap and transducer at the wall of the mouthpiece. For each patient, the inhalationwith the highest PIF value, out of three replicate inhalationsper device, was selected for analysis. A paired t-test was performed to compare mean PIFs between each combination of devices. In total, 97 COPD patients were enrolled and completed the study. The highest mean PIF value (L/min ± SE) was observed with the Breezhaler® (108 ± 23), followed by the Ellipta® (78 ± 15) and the HandiHaler® (49 ± 9) inhalersand the lowest mean pressure drop values were recorded with the Breezhaler® inhaler, followed by the Ellipta® inhalerand the HandiHaler® inhaler, in the overall patient population. A similar trend was consistently observed in patients across all subgroups of COPD severity, within all age groups and for both genders. Patients with COPD were able to inhalewith the least inspiratory effort and generate the highest mean PIF value through the Breezhaler® inhalerwhen compared with the Ellipta® and the HandiHaler® inhalers. These results were similar irrespective of patients’ COPD severity, age or gender. The trial was registered with ClinicalTrials.gov NCT02596009 on 4 November 2015.