NCT00975754

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 11, 2009

Status Verified

December 1, 2009

First QC Date

September 10, 2009

Last Update Submit

December 10, 2009

Conditions

Healthy Volunteers

Keywords

Inhalationlung deposition

Outcome Measures

Primary Outcomes (1)

  • Lung deposition of budesonide (AUC)

    Before dose and repeatadly during the 8-hour period after dose

Study Arms (5)

1

EXPERIMENTAL

Pulmicort pMDI

Drug: Pulmicort pMDI HFA

2

EXPERIMENTAL

Budesonide pMDI

Drug: Budesonide pMDI HFA

3

EXPERIMENTAL

Budesonide pMDI + Aerochamber Zero-stat spacer

Drug: Budesonide pMDI HFA

4

EXPERIMENTAL

Pulmicort repulses via Spira Nebuliser

Drug: Pulmicort Repulses

5

EXPERIMENTAL

Pulmicort Turbohaler

Drug: Pulmicort Turbohaler

Interventions

Pulmicort pMDI HFADRUG

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

1
Budesonide pMDI HFADRUG

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

23
Pulmicort RepulsesDRUG

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

4
Pulmicort TurbohalerDRUG

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

5

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • BMI between 18 and 30 kg/m2
  • Non-smokers/non-snuffers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Lund, Sweden

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carin Jorup

    AstraZeneca R&D Lund, Sweden

    STUDY DIRECTOR

  • Pia Lena Berg

    Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

September 1, 2009

Study Completion

November 1, 2009

Last Updated

December 11, 2009

Record last verified: 2009-12

Locations

SE(1)