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Inspiratory Flow Using the Osmohaler

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00531414
First Posted: September 18, 2007
Last Update Posted: April 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharmaxis
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Inspiratory Flow and VOlumes in Asthmatic and Healthy Individuals Using the Osmohaler

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

Estimated Enrollment: 30
Study Start Date: November 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 69 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • has condition contraindicating performance of spirometrt
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531414


Sponsors and Collaborators
Pharmaxis
Investigators
Principal Investigator: Sandra Anderson Royal Prince Alfred Hospital, Sydney, Australia
  More Information

ClinicalTrials.gov Identifier: NCT00531414     History of Changes
Other Study ID Numbers: DPM-OSM-401
First Submitted: September 16, 2007
First Posted: September 18, 2007
Last Update Posted: April 10, 2008
Last Verified: April 2008

Keywords provided by Pharmaxis:
Asthmatic
healthy