NCT00455130

A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Syntara · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

Cystic fibrosis is the most frequent lethal genetic disease of childhood. Causes disruption of glandular function of the pancreas, intestine, liver, lungs (causing chronic lung infection with emphysema), sweat glands and reproductive organs. We know that many CF patients die of lung failure, brought about in part by repeated lung infections caused by thick, sticky mucus that cannot be readily cleared from the lung. Inhaled mannitol is an osmotic agent that has been investigated in a number of small studies that have examined mucociliary clearance, quality of life and lung function in CF and bronchiectasis. The promising results of these studies warrant futher investigation. The aim of this study is to assess the safety and efficacy of inhaled mannitol when administered twice a day over two weeks in CF.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Inhaled mannitol

Timeline

• Start date: 2004-03-01
• Completion: 2005-08-01
• First posted: 2007-04-03
• Last updated: 2010-02-02

Locations

8 sites across 2 countries: Australia, New Zealand