Study Results
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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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2009-09-30
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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1
Pulmicort pMDI
Pulmicort pMDI HFA
Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
2
Budesonide pMDI
Budesonide pMDI HFA
Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
3
Budesonide pMDI + Aerochamber Zero-stat spacer
Budesonide pMDI HFA
Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
4
Pulmicort repulses via Spira Nebuliser
Pulmicort Repulses
Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations
5
Pulmicort Turbohaler
Pulmicort Turbohaler
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
Budesonide pMDI HFA
Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Pulmicort Repulses
Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations
Pulmicort Turbohaler
Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Eligibility Criteria
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Inclusion Criteria
* BMI between 18 and 30 kg/m2
* Non-smokers/non-snuffers
Exclusion Criteria
* Use of oral contraceptives or hormonal implants
* Known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or other excipients in study drugs
18 Years
45 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
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
Countries
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Other Identifiers
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D5252M00001
Identifier Type: -
Identifier Source: org_study_id
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