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OpenTrials
Completed

NCT Number: NCT00975754

Lung Deposition Via Different Inhalation Devices

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.

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Key information

Conditions

Healthy Volunteers Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Lund, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmicort pMDI HFA

Drug

Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations

Budesonide pMDI HFA

Drug

Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations

Pulmicort Repulses

Drug

Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations

Pulmicort Turbohaler

Drug

Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations

Primary outcomes

  1. Lung deposition of budesonide (AUC)

    Time frame: Before dose and repeatadly during the 8-hour period after dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Sep 11, 2009
Registry last updated
Dec 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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