Pulmonary Disease, Chronic Obstructive (COPD) Clinical Trial
Official title:
Multicenter Open-label Cross-over Study to Compare Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Dry Powder Inhaler Devices
The purpose of this study was to compare dynamic inspiratory flow rates achieved by a population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®, Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active drug or placebo were administered to patients in this study.
The inspiratory flow rates achieved by the COPD patients, via the breath actuated devices,
are one of the important factors that can influence the efficiency of the drug delivery by
the inhalation route. The peak inspiratory flow (PIF) rates achieved by COPD patients through
different breath actuated dry power inhalers may differ because of the differences in
internal resistance of the different type of devices. The results of inspiratory airflow rate
and pressure drop over time, from this study, provided an assessment of the range and
variability of inhalation profile characteristics generated by COPD patients within the
population selected for this study (e.g. demographics, gender, disease control) through the
Breezhaler and the other marketed comparator DPIs.
The inhalation profiles were obtained through an Inhalation Profile Recorder (IPR). The
inhalation profile recorder was a data acquisition device which consists of a computer, an
interface unit and a pressure transducer. This allowed it to measure the real time dynamic
pressure drop at the mouthpiece of the inhaler during an inhalation maneuver. On the graphic
user interface, plots of inspiratory pressure drop versus time and flow rate versus time are
displayed in real time. The investigator or designated study personnel at site was
responsible for typing in the Test Location, selecting the Inhaler Type (Breezhaler, Ellipta,
Handihaler), typing in the Patient ID and Patient Age, selecting Male or Female, and
recording Patient Comments made during the test session, as necessary.
Each patient were required to generate three (03) inhalational profiles through each of the
three (03) study devices: Breezhaler®, Ellipta® and Handihaler®.
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|---|---|---|---|
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