Inspiratory Flow Using the Osmohaler
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531414
|Principal Investigator:||Sandra Anderson||Royal Prince Alfred Hospital, Sydney, Australia|