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

Abstract

BackgroundThe chronic and progressive nature of chronic obstructive pulmonary disease (COPD) requires self-administration of inhaled medication. Dry powder inhalers (DPIs) are increasingly being used for inhalation therapy in COPD. Important considerations when selecting DPIs include inhalation effort 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.MethodsThis randomized, open-label, multicenter, cross-over, Phase IV study recruited patients with moderate to very severe airflow limitation (Global Initiative for Obstructive Lung Disease 2014 strategy), aged ≥40 years and having a smoking history of ≥10 pack years. No active drug or placebo was administered during the study. The inhalation profiles were recorded using inhalers fitted with a pressure tap and transducer at the wall of the mouthpiece. For each patient, the inhalation with the highest PIF value, out of three replicate inhalations per device, was selected for analysis. A paired t-test was performed to compare mean PIFs between each combination of devices.ResultsIn 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) inhalers and the lowest mean pressure drop values were recorded with the Breezhaler® inhaler, followed by the Ellipta® inhaler and 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.ConclusionsPatients with COPD were able to inhale with the least inspiratory effort and generate the highest mean PIF value through the Breezhaler® inhaler when compared with the Ellipta® and the HandiHaler® inhalers. These results were similar irrespective of patients’ COPD severity, age or gender.Trial registrationThe trial was registered with ClinicalTrials.gov NCT02596009 on 4 November 2015. Electronic supplementary materialThe online version of this article (10.1186/s12890-018-0662-0) contains supplementary material, which is available to authorized users.

Does inspiration efficiency influence the stability limits of the trunk in patients with chronic low back pain?

“…VOLUME (L) is the mean in an upright standing position, and verbal encouragement was given to help the subjects perform maximally. For each patient, the highest value of the inhalation, out of 3 repeat inhalations, was selected for analysis (24,25).…”

Inhaler Devices for Delivery of LABA/LAMA Fixed-Dose Combinations in Patients with COPD

“…Among the DPIs that deliver LABA/LAMA, Breezhaler Ò has the lowest airflow resistance, followed by Ellipta Ò and Genuair Ò [61] (Table 2). Moreover, a recent study showed that patients with COPD were able to inhale with the least inspiratory effort and generate the highest mean PIF via the Breezhaler Ò inhaler than with the Ellipta Ò and HandiHaler Ò inhalers, irrespective of patients' COPD severity, age, or gender [62]. Low resistance characteristics could explain patient-reported ''comfort'' inhaling through some devices; the flow rate produced by a standard pressure drop of 4 kPa was greater using Breezhaler Ò than other DPI devices in vitro [63].…”

Peak Inspiratory Flows

“…3 For example, the ability to generate higher inspiratory flows might be limited in patients who have muscle weakness, small stature, or severe to very severe airflow limitation. [13][14][15] A minimal PIF of at least 30 L/ min is suggested for Diskus (GlaxoSmithKline), and of at least 20 L/min for HandiHaler (Boehringer Ingelheim), 8 for the patient to actuate the DPI and inhale the fine drug particles into the lungs; whereas a PIF of at least 60 L/min 8 and of at least 30 L/min 8 or 40 L/min 16 is considered optimal for Diskus and HandiHaler, respectively. Several methods, including the In-Check DIAL device and flow-volume measurements, can be used to measure PIF.…”

“…Previous studies have reported undertaking a total of three consecutive measurements of PIF and using the highest recorded value. 9,11,13,15,18 The American Thoracic Society/ European Respiratory Society spirometry guidelines suggest at least three measurements if the repeatability criteria are met. If repeatability criteria are not met, up to eight measurements can be attempted.…”