A Phase I, Randomized, Open-label, 5-way Crossover, Single Centre Study in Healthy Subjects to Assess the Lung Deposition of Inhaled Budesonide Delivered Via Different Inhalation Devices

AstraZeneca1 site in 1 country16 target enrollmentSeptember 2009

ConditionsHealthy Volunteers

InterventionsPulmicort pMDI HFA Budesonide pMDI HFA Pulmicort Repulses Pulmicort Turbohaler

DrugsPulmicort pMDI HFA Budesonide pMDI HFA Pulmicort Repulses Pulmicort Turbohaler

Overview

Phase: Phase 1
Intervention: Pulmicort pMDI HFA
Conditions: Healthy Volunteers
Sponsor: AstraZeneca
Enrollment: 16
Locations: 1
Primary Endpoint: Lung deposition of budesonide (AUC)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

November 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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