Ignite Creation Date:
2024-05-05 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00656565
Status:
COMPLETED
Last Update Posted:
2008-08-06
First Post:
2008-04-07
Brief Title:
Inspiratory Flow and Volumes in Bronchiectatics
Sponsor:
Syntara
Organization:
Syntara
Study Overview
Official Title:
Inspiratory Flow Rates and Volumes in Subjects With Bronchiectasis Using Low and High Resistance Dry Powder Inhaler Devices
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
We propose that the majority of subjects investigated with varying lung function will achieve adequate flow during a controlled inspiration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None