Trials / Completed
CompletedNCT00251056
Mannitol Dose Response Study in Cystic Fibrosis
A Phase IIa Randomised, Open Label, Dose Response Study to Determine the Optimum Dose of Dry Powder Mannitol Required to Generate Clinical Improvement In Patients With Cystic Fibrosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Syntara · Industry
- Sex
- All
- Age
- 7 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mannitol | 120mg BD |
| DRUG | mannitol | 40 mg BD |
| DRUG | mannitol | 240mg BD |
| DRUG | mannitol | 400mg BD |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2005-11-09
- Last updated
- 2008-08-29
Locations
12 sites across 2 countries: Argentina, Canada
Source: ClinicalTrials.gov record NCT00251056. Inclusion in this directory is not an endorsement.