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Inspiratory Flow and Volumes in Bronchiectatics
This study has been completed.
Sponsored by: Pharmaxis
Information provided by: Pharmaxis
ClinicalTrials.gov Identifier: NCT00656565
  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

U.S. FDA Resources
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • inspiratory volume [ Time Frame: single visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656565

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

Responsible Party: Royal Prince Alfred Hospital ( Dr Sandra Anderson )
Study ID Numbers: DPM-OSM-402
Study First Received: April 7, 2008
Last Updated: August 5, 2008
ClinicalTrials.gov Identifier: NCT00656565  
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Study placed in the following topic categories:
Respiratory Tract Diseases
Bronchiectasis

Additional relevant MeSH terms:
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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