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Lung Deposition Via Different Inhalation Devices

NCT ID: NCT00975754

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Inhalation lung deposition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Pulmicort pMDI

Group Type EXPERIMENTAL

Pulmicort pMDI HFA

Intervention Type DRUG

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

2

Budesonide pMDI

Group Type EXPERIMENTAL

Budesonide pMDI HFA

Intervention Type DRUG

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

3

Budesonide pMDI + Aerochamber Zero-stat spacer

Group Type EXPERIMENTAL

Budesonide pMDI HFA

Intervention Type DRUG

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

4

Pulmicort repulses via Spira Nebuliser

Group Type EXPERIMENTAL

Pulmicort Repulses

Intervention Type DRUG

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

5

Pulmicort Turbohaler

Group Type EXPERIMENTAL

Pulmicort Turbohaler

Intervention Type DRUG

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

Interventions

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Pulmicort pMDI HFA

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

Intervention Type DRUG

Budesonide pMDI HFA

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

Intervention Type DRUG

Pulmicort Repulses

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

Intervention Type DRUG

Pulmicort Turbohaler

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Lund

Principal Investigators

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Carin Jorup

Role: STUDY_DIRECTOR

AstraZeneca R&D Lund, Sweden

Pia Lena Berg

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden

Locations

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Research Site

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D5252M00001

Identifier Type: -

Identifier Source: org_study_id