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Inspiratory Flow and Volumes in Bronchiectatics

NCT ID: NCT00656565

Last Updated: 2008-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-07-31

Brief Summary

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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

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Conditions

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Bronchiectasis

Keywords

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

Study Groups

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1

subjects with bronchiectasis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syntara

INDUSTRY

Sponsor Role lead

Responsible Party

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Royal Prince Alfred Hospital

Locations

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Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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DPM-OSM-402

Identifier Type: -

Identifier Source: org_study_id