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Lung Deposition Via Different Inhalation Devices

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00975754
First received: September 10, 2009
Last updated: December 10, 2009
Last verified: December 2009
History of Changes
  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 1

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 May 23, 2013