Back to resultsLung Deposition Via Different Inhalation Devices
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Pulmicort pMDI HFA
Budesonide pMDI HFA
Pulmicort Repulses
Pulmicort Turbohaler
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Volunteers focused on measuring Inhalation, lung deposition
Eligibility Criteria
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
Arm Description
Pulmicort pMDI
Budesonide pMDI
Budesonide pMDI + Aerochamber Zero-stat spacer
Pulmicort repulses via Spira Nebuliser
Pulmicort Turbohaler
Outcomes
Primary Outcome Measures
Lung deposition of budesonide (AUC)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00975754
Brief Title
Lung Deposition Via Different Inhalation Devices
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Inhalation, lung deposition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pulmicort pMDI
Arm Title
2
Arm Type
Experimental
Arm Description
Budesonide pMDI
Arm Title
3
Arm Type
Experimental
Arm Description
Budesonide pMDI + Aerochamber Zero-stat spacer
Arm Title
4
Arm Type
Experimental
Arm Description
Pulmicort repulses via Spira Nebuliser
Arm Title
5
Arm Type
Experimental
Arm Description
Pulmicort Turbohaler
Intervention Type
Drug
Intervention Name(s)
Pulmicort pMDI HFA
Intervention Description
Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Intervention Type
Drug
Intervention Name(s)
Budesonide pMDI HFA
Intervention Description
Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Intervention Type
Drug
Intervention Name(s)
Pulmicort Repulses
Intervention Description
Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations
Intervention Type
Drug
Intervention Name(s)
Pulmicort Turbohaler
Intervention Description
Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Primary Outcome Measure Information:
Title
Lung deposition of budesonide (AUC)
Time Frame
Before dose and repeatadly during the 8-hour period after dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carin Jorup
Organizational Affiliation
AstraZeneca R&D Lund, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pia Lena Berg
Organizational Affiliation
Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Lund
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Lung Deposition Via Different Inhalation Devices
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