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Inspiratory Flow and Volumes in Bronchiectatics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656565
First Posted: April 11, 2008
Last Update Posted: August 6, 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

Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory flow rates and volumes. These vary according to the device being used and its resistance. The dry powder inhaler device under investigation is a device approved by the Therapeutic Goods Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is currently being investigated as a treatment for bronchiectasis. We wish to measure the inspiratory flow characteristics of both the low and high resistance devices amongst a group of subjects with bronchiectasis.

We propose that the majority of subjects investigated with varying lung function will achieve adequate flow during a controlled inspiration.


Condition
Bronchiectasis

Study Type: Observational
Official Title: Inspiratory Flow Rates and Volumes in Subjects With Bronchiectasis Using Low and High Resistance Dry Powder Inhaler Devices

Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • inspiratory flow [ Time Frame: single visit ]

Secondary Outcome Measures:
  • inspiratory volume [ Time Frame: single visit ]

Estimated Enrollment: 15
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
subjects with bronchiectasis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects aged 18-80 years, with bronchiectasis and FEV1 greater or equal to 50% predicted and greater or equal to 1L
Criteria

Inclusion Criteria:

  • non-cf bronchiectasis
  • aged 18-80 inclusive
  • FEV1 greater or equal to 50% predicted and greater or equal to 1L

Exclusion Criteria:

  • uncontrolled asthma
  • CF bronchiectasis
  • have any condition for which spirometry measurement would be contraindicated
  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): NCT00656565


Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Sponsors and Collaborators
Pharmaxis
  More Information

Responsible Party: Dr Sandra Anderson, Royal Prince Alfred Hospital
ClinicalTrials.gov Identifier: NCT00656565     History of Changes
Other Study ID Numbers: DPM-OSM-402
First Submitted: April 7, 2008
First Posted: April 11, 2008
Last Update Posted: August 6, 2008
Last Verified: August 2008

Keywords provided by Pharmaxis:
measure inspiratory spirometry with dry powder inhaler device in series with the spirometer

Additional relevant MeSH terms:
Respiratory Aspiration
Bronchiectasis
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases