NCT00656565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 6, 2008

Status Verified

August 1, 2008

Enrollment Period

1 month

First QC Date

April 7, 2008

Last Update Submit

August 5, 2008

Conditions

Bronchiectasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • inspiratory flow

    single visit

Secondary Outcomes (1)

  • inspiratory volume

    single visit

Study Arms (1)

1

subjects with bronchiectasis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

August 6, 2008

Record last verified: 2008-08

Locations

AU(1)