NCT00730977

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.

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 phase_1 healthy

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_1 healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

1 month

First QC Date

August 5, 2008

Last Update Submit

September 17, 2009

Conditions

HealthyBronchiectasis

Outcome Measures

Primary Outcomes (1)

  • tolerability

    immediately and 10 mins post dose

Secondary Outcomes (1)

  • respiratory symptoms, FEV1

    pre-dose, immediately and 10 mins post dose

Study Arms (1)

single

EXPERIMENTAL

single arm, open label, 4 doses tested.

Drug: dry powder inhaled mannitol

Interventions

dry powder inhaled mannitolDRUG

single doses of 40 mg, 70 mg and 100 mg

single

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy or bronchiectatic; 18 years and over

You may not qualify if:

  • uncontrolled asthma, unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Prince Alfred Hospital

Sydney, Australia

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

August 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

AU(1)