Lung Deposition Via Different Inhalation Devices

December 10, 2009 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Pulmicort pMDI
Drug: Pulmicort pMDI HFA
Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Experimental: 2
Budesonide pMDI
Drug: Budesonide pMDI HFA
Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Experimental: 3
Budesonide pMDI + Aerochamber Zero-stat spacer
Drug: Budesonide pMDI HFA
Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Experimental: 4
Pulmicort repulses via Spira Nebuliser
Drug: Pulmicort Repulses
Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations
Experimental: 5
Pulmicort Turbohaler
Drug: Pulmicort Turbohaler
Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Carin Jorup, AstraZeneca R&D Lund, Sweden
  • Principal Investigator: Pia Lena Berg, Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 10, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5252M00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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