Lung Deposition Via Different Inhalation Devices

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00975754

Enrollment

Registered

2009-09-11

Start date

2009-09-30

Completion date

2009-11-30

Last updated

2009-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Inhalation, lung deposition

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.

Interventions

DRUGPulmicort pMDI HFA

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

DRUGBudesonide pMDI HFA

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

DRUGPulmicort Repulses

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

DRUGPulmicort Turbohaler

Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Lung deposition of budesonide (AUC)	Before dose and repeatadly during the 8-hour period after dose

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026