Back to resultsInspiratory Flow and Volumes in Bronchiectatics
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Locations
Australia
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Bronchiectasis focused on measuring measure inspiratory spirometry with dry powder inhaler device in series with the spirometer
Eligibility 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
Sites / Locations
- Royal Prince Alfred Hospital
Arms of the Study
Arm 1
Arm Type
Arm Label
1
Arm Description
subjects with bronchiectasis
Outcomes
Primary Outcome Measures
inspiratory flow
Secondary Outcome Measures
inspiratory volume
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00656565
Brief Title
Inspiratory Flow and Volumes in Bronchiectatics
Official Title
Inspiratory Flow Rates and Volumes in Subjects With Bronchiectasis Using Low and High Resistance Dry Powder Inhaler Devices
Study Type
Observational
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmaxis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
measure inspiratory spirometry with dry powder inhaler device in series with the spirometer
7. Study Design
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Description
subjects with bronchiectasis
Primary Outcome Measure Information:
Title
inspiratory flow
Time Frame
single visit
Secondary Outcome Measure Information:
Title
inspiratory volume
Time Frame
single visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
subjects aged 18-80 years, with bronchiectasis and FEV1 greater or equal to 50% predicted and greater or equal to 1L
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
12. IPD Sharing Statement
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Inspiratory Flow and Volumes in Bronchiectatics
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