MedTrace Logo

Inspiratory Flow Using the Osmohaler

NCT00531414 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2008-04-10

No results posted yet for this study

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

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Sandra Anderson · Royal Prince Alfred Hospital, Sydney, Australia

Eligibility

Min Age
6 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-02-29
Completion
2008-02-29

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00531414 on ClinicalTrials.gov