Lung Deposition Via Different Inhalation Devices - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00975754

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: Pulmicort pMDI HFA Drug: Budesonide pMDI HFA Drug: Pulmicort Repulses Drug: Pulmicort Turbohaler	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
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

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Lung deposition of budesonide (AUC) [ Time Frame: Before dose and repeatadly during the 8-hour period after dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	September 2009
Study Completion Date:	November 2009

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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975754

Locations

Sweden
Research Site
Lund, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Carin Jorup	AstraZeneca R&D Lund, Sweden
Principal Investigator:	Pia Lena Berg	Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden

More Information

No publications provided

Responsible Party:	MSD Carin Jorup, MD, Emerging respiratory, AstraZeneca R&D Lund
ClinicalTrials.gov Identifier:	NCT00975754 History of Changes
Other Study ID Numbers:	D5252M00001
Study First Received:	September 10, 2009
Last Updated:	December 10, 2009
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Inhalation
lung deposition

Additional relevant MeSH terms:

Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012