NCT00642122

Brief Summary

A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Apr 2003

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

1.7 years

First QC Date

March 18, 2008

Last Update Submit

January 21, 2011

Conditions

Asthma

Keywords

AsthmaPulmicortbudesoniderespulesturbuhaler

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.

    Day -14, 1, and every 28 days thereafter

Secondary Outcomes (3)

  • Percentage of symptom free days

    Day -14, 1, and every 28 days thereafter

  • Percentage of symptom free nights

    Day -14, 1, and every 28 days thereafter

  • Percentage of symptom free 24-hours

    Day -14, 1, and every 28 days thereafter

Study Arms (2)

1

EXPERIMENTAL

Pulmicort RESPULES

Drug: Budesonide

2

EXPERIMENTAL

Pulmicort TURBUHALER

Drug: Budesonide

Interventions

BudesonideDRUG

0.5mg once daily

Also known as: Pulmicort RESPULES
1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 12 or over who have asthma
  • Ability to properly use an electronic diary
  • Able and willing to nebulize for up to 20 minutes every morning and evening

You may not qualify if:

  • Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
  • Planned hospitalisation during the study
  • pregnant women or women planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bertil Andersson

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

April 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

January 24, 2011

Record last verified: 2011-01