Lung Deposition Via Different Inhalation Devices

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Budesonide pMDI HFA; Drug: Pulmicort Turbohaler; Drug: Pulmicort pMDI HFA; Drug: Pulmicort Repulses

• Registration Number: NCT00975754
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Study Completion: 2009-11
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-10
• Last Update Posted: 2009-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	Budesonide pMDI HFA	Budesonide pMDI + Aerochamber Zero-stat spacer
5	Pulmicort Turbohaler	Pulmicort Turbohaler
1	Pulmicort pMDI HFA	Pulmicort pMDI
2	Budesonide pMDI HFA	Budesonide pMDI
4	Pulmicort Repulses	Pulmicort repulses via Spira Nebuliser

Primary Outcome Measures

Name	Time	Method
Lung deposition of budesonide (AUC)	Before dose and repeatadly during the 8-hour period after dose

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden