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Lung Deposition Via Different Inhalation Devices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975754
First Posted: September 11, 2009
Last Update Posted: December 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: MSD Carin Jorup, MD, Emerging respiratory, AstraZeneca R&D Lund
ClinicalTrials.gov Identifier: NCT00975754     History of Changes
Other Study ID Numbers: D5252M00001
First Submitted: September 10, 2009
First Posted: September 11, 2009
Last Update Posted: December 11, 2009
Last Verified: December 2009

Keywords provided by AstraZeneca:
Inhalation
lung deposition

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists