Asthma Clinical Trial
Official title:
Inspiratory Flow and VOlumes in Asthmatic and Healthy Individuals Using the Osmohaler
The OsmohalerTM is a registered device in Australia. It is used to deliver a dry powder a
commercial preparation of mannitol registered as AridolTM to test if a person has irritable
airways such as active asthma.
The overseas regulatory authorities need to know that people of all ages can achieve an
adequate inspiratory flow through this device during a controlled deep inspiration. Adequate
flow is generally regarded as greater than 30 litres per minute in children and 60 litres
per minute in adults. The OsmohalerTM is a device with low resistance and is already in use
in Australia to deliver mannitol. However there is a need to document inspiratory flows
through the device during a controlled deep inspiration. The protocol requires subjects to
perform a controlled deep inspiration from the device on three or five occasions. No
substance will be inhaled.
n/a
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