Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00531414
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2007-09-16
Brief Title:
Inspiratory Flow Using the Osmohaler
Sponsor:
Syntara
Organization:
Syntara
Study Overview
Official Title:
Inspiratory Flow and VOlumes in Asthmatic and Healthy Individuals Using the Osmohaler
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None