Inspiratory Flow and Volumes in Bronchiectatics

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656565
• Other study ID #: DPM-OSM-402
• Status: Completed
• Phase: N/A
• First received: April 7, 2008
• Last updated: August 5, 2008
• Start date: June 2008
• Est. completion date: July 2008

Study information

• Verified date: August 2008
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Bronchiectasis
• Respiratory Aspiration

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inspiratory flow		single visit	No
Secondary	inspiratory volume		single visit	No