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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
  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:


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
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, see Learn About Clinical Studies.

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
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014