Inspiratory Flow and Volumes in Bronchiectatics

Completed

• Conditions: Bronchiectasis

• Registration Number: NCT00656565
• Lead Sponsor: Syntara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-11
• Study Start: 2008-06
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-05
• Last Update Posted: 2008-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
inspiratory flow	single visit

Secondary Outcome Measures

Name	Time	Method
inspiratory volume	single visit

Trial Locations

Locations (1)

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia