Lung Deposition Via Different Inhalation Devices

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Pulmicort Repulses; Drug: Pulmicort Turbohaler; Drug: Pulmicort pMDI HFA; Drug: Budesonide pMDI HFA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975754

D5252M00001

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 5 patient groups

1

Experimental group

Description:

Pulmicort pMDI

Treatment:

Drug: Pulmicort pMDI HFA

2

Experimental group

Description:

Budesonide pMDI

Treatment:

Drug: Budesonide pMDI HFA

3

Experimental group

Description:

Budesonide pMDI + Aerochamber Zero-stat spacer

Treatment:

Drug: Budesonide pMDI HFA

4

Experimental group

Description:

Pulmicort repulses via Spira Nebuliser

Treatment:

Drug: Pulmicort Repulses

5

Experimental group

Description:

Pulmicort Turbohaler

Treatment:

Drug: Pulmicort Turbohaler