Asthma Clinical Trial
Phase IIa, single-centre, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler® device in adult asthmatic patients with varying degrees of disease control.
The primary objective of this study is to assess the inspiratory flow profile through the
NEXThaler® device in adult asthmatics with varying degrees of disease control.
The study plan foresees one visit at clinic. At Visit 1, after the signature of the informed
consent form, the inclusion/exclusion criteria will be checked and the lung function
parameters will be evaluated. If the subjects meet the inclusion/exclusion criteria, they
will be instructed to use the NEXThaler®. The patients will subsequently inhale through the
device and the inspiration profile will be measured.
A total of 40 asthmatic adults (≥18 years), 20 with controlled stable disease and 20 with
partly controlled or uncontrolled disease according to GINA guidelines (2011), will be
enrolled.
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