High Dose Inhaled Mannitol Study

Syntara

Status and phase: Completed; Phase 2; Phase 1

Conditions: Bronchiectasis

Treatments: Drug: mannitol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01076491

DPM-DEV-102b (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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