Inspiratory Flow Using the Osmohaler

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthmatic healthy

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* has condition contraindicating performance of spirometrt

Minimum Eligible Age

6 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Sandra Anderson

Role: PRINCIPAL_INVESTIGATOR

Royal Prince Alfred Hospital, Sydney, Australia

Other Identifiers

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DPM-OSM-401

Identifier Type: -

Identifier Source: org_study_id