Lung Deposition Via Different Inhalation Devices

AstraZeneca16 enrolled

Overview

The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Pulmicort pMDI HFADRUG

Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations

Budesonide pMDI HFADRUG

Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations

Pulmicort RepulsesDRUG

Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * BMI between 18 and 30 kg/m2 * Non-smokers/non-snuffers Exclusion Criteria: * Pregnant and/or lactating women * Use of oral contraceptives or hormonal implants * Known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or other excipients in study drugs

Locations (1)

Research Site

Lund, Sweden

Outcomes

Primary Outcomes

Lung deposition of budesonide (AUC)

Time frame: Before dose and repeatadly during the 8-hour period after dose

Data from ClinicalTrials.gov

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