Inspiratory Flow and Volumes in Bronchiectatics

August 5, 2008 updated by: Pharmaxis

Inspiratory Flow Rates and Volumes in Subjects With Bronchiectasis Using Low and High Resistance Dry Powder Inhaler Devices

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

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?

Cohorts and Interventions

Group / Cohort
1
subjects with bronchiectasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
inspiratory flow
Time Frame: single visit
single visit

Secondary Outcome Measures

Outcome Measure
Time Frame
inspiratory volume
Time Frame: single visit
single visit

Collaborators and Investigators

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

Sponsor

Pharmaxis

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

June 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

April 7, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (Estimate)

April 11, 2008

Study Record Updates

Last Update Posted (Estimate)

August 6, 2008

Last Update Submitted That Met QC Criteria

August 5, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPM-OSM-402

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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