Study 17 of 34 for search of: "Bronchiectasis"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device
This study is currently recruiting participants.
Verified by Pharmaxis, August 2008
Sponsored by: Pharmaxis
Information provided by: Pharmaxis
ClinicalTrials.gov Identifier: NCT00730977
  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 I
Phase II

Drug Information available for: Mannitol
U.S. FDA Resources
Study Type: Interventional
Study Design: Open Label, Uncontrolled, Single Group Assignment, Safety Study
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.

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 ]

Estimated Enrollment: 15
Study Start Date: August 2008
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single: Experimental
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730977

Contacts
Contact: Iven H Young, MBBS 61295156111

Locations
Australia
Royal Prince Alfred Hospital Recruiting
Sydney, Australia
Contact: Iven H Young, MBBS            
Principal Investigator: Iven H Young            
Sponsors and Collaborators
Pharmaxis
  More Information

Responsible Party: Pharmaxis Ltd ( Brett Charlton )
Study ID Numbers: DPM-DEV-101b
Study First Received: August 5, 2008
Last Updated: August 27, 2008
ClinicalTrials.gov Identifier: NCT00730977  
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:
Respiratory Tract Diseases
Mannitol
Bronchiectasis
Healthy

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

ClinicalTrials.gov processed this record on January 16, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services