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

Phase 1

Completed

• Conditions: Healthy; Bronchiectasis
• Interventions: Drug: dry powder inhaled mannitol

• Registration Number: NCT00730977
• Lead Sponsor: Syntara

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• healthy or bronchiectatic; 18 years and over

Exclusion Criteria

• uncontrolled asthma, unstable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single	dry powder inhaled mannitol	single arm, open label, 4 doses tested.

Primary Outcome Measures

Name	Time	Method
tolerability	immediately and 10 mins post dose

Secondary Outcome Measures

Name	Time	Method
respiratory symptoms, FEV1	pre-dose, immediately and 10 mins post dose

Trial Locations

Locations (1)

Royal Prince Alfred Hospital; 🇦🇺 Sydney, Australia