High Dose Inhaled Mannitol Study

Bronchiectasis Clinical Trial

Official title:

A Pilot Study to Investigate the Feasibility and Tolerability of Inhaling a High Dose of Dry Powder Mannitol (IDPM) Per Breath Administered Via a Dry Powder Inhaler Loaded With a Single Capsule in Subjects With Bronchiectasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076491
• Other study ID #: DPM-DEV-102b
• Secondary ID: DPM-DEV-102b
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 11, 2009
• Last updated: February 24, 2010
• Start date: January 2009
• Est. completion date: April 2009

Study information

• Verified date: February 2010
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

This study is to investigate the safety and tolerability of high doses of inhaled mannitol in subjects with bronchiectasis to further direct development of an improved drug delivery system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult subjects with non-CF bronchiectasis

• FEV1 > 50 % predicted and > 1.0L

Exclusion Criteria:

• bronchiectasis due to CF or endobronchial lesion

• respiratory infection requiring IV antibiotics in last 4 weeks

• pregnancy

• significant haemoptysis in last 6 months

• active TB

• end stage ILD

• contraindications as determined by investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• mannitol
inhaled mannitol - single doses of either 70 mg or 90 mg

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	emitted dose		single measure	No