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

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00730977
First received: August 5, 2008
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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: 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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00730977

Locations
Australia
Royal Prince Alfred Hospital
Sydney, Australia
Sponsors and Collaborators
Pharmaxis
  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:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014