Lung Deposition Via Different Inhalation Devices

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00975754
First received: September 10, 2009
Last updated: December 10, 2009
Last verified: December 2009

September 10, 2009
December 10, 2009
September 2009
Not Provided
Lung deposition of budesonide (AUC) [ Time Frame: Before dose and repeatadly during the 8-hour period after dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00975754 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Pulmicort pMDI HFA
    Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
  • Drug: Budesonide pMDI HFA
    Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
  • Drug: Pulmicort Repulses
    Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations
  • Drug: Pulmicort Turbohaler
    Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
  • Experimental: 1
    Pulmicort pMDI
    Intervention: Drug: Pulmicort pMDI HFA
  • Experimental: 2
    Budesonide pMDI
    Intervention: Drug: Budesonide pMDI HFA
  • Experimental: 3
    Budesonide pMDI + Aerochamber Zero-stat spacer
    Intervention: Drug: Budesonide pMDI HFA
  • Experimental: 4
    Pulmicort repulses via Spira Nebuliser
    Intervention: Drug: Pulmicort Repulses
  • Experimental: 5
    Pulmicort Turbohaler
    Intervention: Drug: Pulmicort Turbohaler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2009
Not Provided

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00975754
D5252M00001
No
MSD Carin Jorup, MD, Emerging respiratory, AstraZeneca R&D Lund
AstraZeneca
Not Provided
Study Director: Carin Jorup AstraZeneca R&D Lund, Sweden
Principal Investigator: Pia Lena Berg Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden
AstraZeneca
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP