Inspiratory Flow Using the Osmohaler

Inspiratory Flow and VOlumes in Asthmatic and Healthy Individuals Using the Osmohaler

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00531414

Enrollment

Registered

2007-09-18

Start date

2007-11-30

Completion date

2008-02-29

Last updated

2008-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthmatic, healthy

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 69 Years

Healthy volunteers

Yes

Inclusion criteria

* has asthma or is healthy * aged 6 to 69 years inclusive * FEV1 \>/= 70% predicted

Exclusion criteria

* has condition contraindicating performance of spirometrt

Outcome results