drugset / Trial / NCT00251056

Mannitol Dose Response Study in Cystic Fibrosis

NCT00251056

Phase 2 Completed 48 enrolled Syntara
RandomizedCrossoverOpen-labelTreatment

Summary

Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology and replenishing the airway surface liquid layer in these patients, thereby enhancing the shift of stagnant mucus from the lungs. The study aim is to determine the optimal dose of mannitol to generate clinical improvement in patients with cystic fibrosis.

Timeline

Start
2005-10
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mannitol Diagnostic / imaging agent 40 mg Inhaled
Comparator Mannitol Diagnostic / imaging agent 120 mg Inhaled
Comparator Mannitol Diagnostic / imaging agent 240 mg Inhaled
Comparator Mannitol Diagnostic / imaging agent 400 mg Inhaled

Indications