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

Syntara15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Healthy Bronchiectasis

Interventions

dry powder inhaled mannitolDRUG

single doses of 40 mg, 70 mg and 100 mg

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy or bronchiectatic; 18 years and over Exclusion Criteria: * uncontrolled asthma, unstable

Locations (1)

Royal Prince Alfred Hospital

Sydney, Australia

Outcomes

Primary Outcomes

tolerability

Time frame: immediately and 10 mins post dose

Secondary Outcomes

respiratory symptoms, FEV1

Time frame: pre-dose, immediately and 10 mins post dose

Data from ClinicalTrials.gov

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