A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device

Syntara

Status and phase: Completed; Phase 2; Phase 1

Conditions: Bronchiectasis; Healthy

Treatments: Drug: dry powder inhaled mannitol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730977

DPM-DEV-101b

Details and patient eligibility

About

A novel dry powder inhaler device will be used to administer mannitol to healthy subjects and subjects with bronchiectasis in single doses higher than previously given.The main objective is to assess tolerability of these doses using the new device.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy or bronchiectatic; 18 years and over

Exclusion criteria

• uncontrolled asthma, unstable

Trial design

15 participants in 1 patient group

single

Experimental group

Description:

single arm, open label, 4 doses tested.

Treatment:

Drug: dry powder inhaled mannitol