This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Pharmaxis 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
Healthy Bronchiectasis Drug: dry powder inhaled mannitol Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy or bronchiectatic; 18 years and over

Exclusion Criteria:

  • uncontrolled asthma, unstable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00730977

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

Responsible Party: Brett Charlton, Pharmaxis Ltd Identifier: NCT00730977     History of Changes
Other Study ID Numbers: DPM-DEV-101b
Study First Received: August 5, 2008
Last Updated: September 17, 2009

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs processed this record on August 18, 2017