Inspiratory Flow Using the Osmohaler

April 7, 2008 updated by: Pharmaxis

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • has condition contraindicating performance of spirometrt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmaxis

Investigators

  • Principal Investigator: Sandra Anderson, Royal Prince Alfred Hospital, Sydney, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 16, 2007

First Submitted That Met QC Criteria

September 17, 2007

First Posted (Estimate)

September 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 7, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPM-OSM-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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