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

September 17, 2009 updated by: Pharmaxis

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia
        • Royal Prince Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy or bronchiectatic; 18 years and over

Exclusion Criteria:

  • uncontrolled asthma, unstable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single
single arm, open label, 4 doses tested.
Drug: dry powder inhaled mannitol
single doses of 40 mg, 70 mg and 100 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
tolerability
Time Frame: immediately and 10 mins post dose
immediately and 10 mins post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
respiratory symptoms, FEV1
Time Frame: pre-dose, immediately and 10 mins post dose
pre-dose, immediately and 10 mins post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmaxis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPM-DEV-101b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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