Lung deposition via different inhalation devices
Study identifier:D5252M00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Pulmicort pMDI HFA, Budesonide pMDI HFA, Pulmicort Repulses, Pulmicort Turbohaler
Sex
All
Actual Enrollment
16
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Sept 2009
Primary Completion Date: -
Study Completion Date: 01 Nov 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 |
Contacts
Investigators
Principal Investigator
Carin Jorup
AstraZeneca R&D Lund, Sweden
