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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: August 5, 2008
Last updated: September 17, 2009
Last verified: September 2009
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.

Condition Intervention Phase
Drug: dry powder inhaled mannitol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • tolerability [ Time Frame: immediately and 10 mins post dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • respiratory symptoms, FEV1 [ Time Frame: pre-dose, immediately and 10 mins post dose ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single
single arm, open label, 4 doses tested.
Drug: dry powder inhaled mannitol
single doses of 40 mg, 70 mg and 100 mg


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy or bronchiectatic; 18 years and over

Exclusion Criteria:

  • uncontrolled asthma, unstable
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00730977

Royal Prince Alfred Hospital
Sydney, Australia
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Brett Charlton, Pharmaxis Ltd
ClinicalTrials.gov Identifier: NCT00730977     History of Changes
Other Study ID Numbers: DPM-DEV-101b 
Study First Received: August 5, 2008
Last Updated: September 17, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Cardiovascular Agents
Diuretics, Osmotic
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 04, 2016