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

A Pilot Study to Investigate the Tolerability of Inhaled Dry Powder Mannitol (IDPM) Administered Via a Novel Dry Powder Inhaler Device in Healthy Individuals and Subjects With Bronchiectasis.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00730977

Enrollment

Registered

2008-08-08

Start date

2008-08-31

Completion date

2008-09-30

Last updated

2009-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis, Healthy

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.

Interventions

DRUGdry powder inhaled mannitol

single doses of 40 mg, 70 mg and 100 mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* healthy or bronchiectatic; 18 years and over

Exclusion criteria

* uncontrolled asthma, unstable

Design outcomes

Primary

Measure	Time frame
tolerability	immediately and 10 mins post dose

Secondary

Measure	Time frame
respiratory symptoms, FEV1	pre-dose, immediately and 10 mins post dose

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026