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CompletedNCT00656565Updated Aug 6, 2008

Inspiratory Flow and Volumes in Bronchiectatics

An observational study in Bronchiectasis, sponsored by Syntara. Completed at 1 site in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-08-06.

Sponsored by Syntara · Observational

Study type
Observational
Enrollment
15
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchiectasis

Keywords

  • measure inspiratory spirometry with dry powder inhaler device in series with the spirometer
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 15 is below the median of 65 across 184 observational studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Syntara is the lead sponsor of 29 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

subjects aged 18-80 years, with bronchiectasis and FEV1 greater or equal to 50% predicted and greater or equal to 1L

Inclusion criteria

  • non-cf bronchiectasis
  • aged 18-80 inclusive
  • FEV1 greater or equal to 50% predicted and greater or equal to 1L

Exclusion criteria

Exclusion Criteria:

  • uncontrolled asthma
  • CF bronchiectasis
  • have any condition for which spirometry measurement would be contraindicated
05

Study design

Enrollment
15 participants (estimated)

Groups and cohorts

  • 1

    subjects with bronchiectasis

06

What researchers measure

Primary outcomes

  1. inspiratory flow

    Time frame: single visit

Secondary outcomes

  1. inspiratory volume

    Time frame: single visit

07

Study locations

1 site
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales 2050, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00656565
Lead sponsor
Syntara
First posted
Apr 11, 2008
Start date
Jun 2008
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Aug 6, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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