Trials / Completed
CompletedNCT00531414
Inspiratory Flow Using the Osmohaler
Inspiratory Flow and VOlumes in Asthmatic and Healthy Individuals Using the Osmohaler
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- Syntara · Industry
- Sex
- All
- Age
- 6 Years – 69 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2007-09-18
- Last updated
- 2008-04-10
Source: ClinicalTrials.gov record NCT00531414. Inclusion in this directory is not an endorsement.