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A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device

NCT ID: NCT00730977

Last Updated: 2009-09-18

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

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-09-30

Brief Summary

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A novel dry powder inhaler device will be used to administer mannitol to healthy subjects and subjects with bronchiectasis in single doses higher than previously given.The main objective is to assess tolerability of these doses using the new device.

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Detailed Description

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Conditions

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Healthy Bronchiectasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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single

single arm, open label, 4 doses tested.

Group Type EXPERIMENTAL

dry powder inhaled mannitol

Intervention Type DRUG

single doses of 40 mg, 70 mg and 100 mg

Interventions

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dry powder inhaled mannitol

single doses of 40 mg, 70 mg and 100 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy or bronchiectatic; 18 years and over

Exclusion Criteria

* uncontrolled asthma, unstable
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syntara

INDUSTRY

Sponsor Role lead

Responsible Party

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Pharmaxis Ltd

Locations

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Royal Prince Alfred Hospital

Sydney, , Australia

Site Status

Countries

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Australia

Other Identifiers

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DPM-DEV-101b

Identifier Type: -

Identifier Source: org_study_id

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