Safety and Efficacy of Bronchitol in Bronchiectasis

Syntara

Status and phase

Completed

Phase 3

Conditions

Bronchiectasis

Treatments

Drug: placebo

Drug: Mannitol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00277537

DPM-B-301

Details and patient eligibility

About

Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.

Enrollment

354 estimated patients

Sex

All

Ages

15 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Non cystic fibrosis bronchiectasis
Have FEV1 50% - 80% predicted and ≥1.0L
Have chronic sputum production of >10 mL per day on the majority of days in the 3 months prior to study entry

Exclusion criteria

Be using hypertonic saline or mucolytic pharmacological agents concurrently or in the 4 weeks prior to study entry
Have airway hyperresponsiveness as defined by a positive Aridol challenge