Inspiratory Flow Using the Osmohaler
|ClinicalTrials.gov Identifier: NCT00531414|
Recruitment Status : Completed
First Posted : September 18, 2007
Last Update Posted : April 10, 2008
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Inspiratory Flow and VOlumes in Asthmatic and Healthy Individuals Using the Osmohaler|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531414
|Principal Investigator:||Sandra Anderson||Royal Prince Alfred Hospital, Sydney, Australia|