Inspiratory Flow and Volumes in Bronchiectatics

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00656565

Enrollment

Registered

2008-04-11

Start date

2008-06-30

Completion date

2008-07-31

Last updated

2008-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Keywords

measure inspiratory spirometry with dry powder inhaler device in series with the spirometer

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
inspiratory flow	single visit

Secondary

Measure	Time frame
inspiratory volume	single visit

Countries

Australia

Outcome results