NCT00646529

Brief Summary

The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years

Trial Health

100
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Jul 2002

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

July 1, 2002

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

March 30, 2009

Status Verified

March 1, 2009

First QC Date

March 26, 2008

Last Update Submit

March 27, 2009

Conditions

Asthma

Keywords

asthmachildrenSymbicortbudesonide/formoterolPulmicortbudesonide

Outcome Measures

Primary Outcomes (1)

  • Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol

    4 assessments within 26 week treatment period

Secondary Outcomes (1)

  • Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort

    4 assessments within 26 week treatment period

Study Arms (2)

1

EXPERIMENTAL

budesonide/formoterol

Drug: budesonide/formoterol (Symbicort)

2

ACTIVE COMPARATOR

budesonide

Drug: budesonide (Pulmicort)

Interventions

budesonide/formoterol (Symbicort)DRUG
Also known as: Symbicort
1
budesonide (Pulmicort)DRUG
Also known as: Pulmicort
2

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • At least 6 and maximally 11 years of age
  • Diagnosis of asthma
  • Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start

You may not qualify if:

  • Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
  • Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

BudesonideFormoterol FumarateBudesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Catherine Bonuccelli

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 28, 2008

Study Start

July 1, 2002

Study Completion

October 1, 2003

Last Updated

March 30, 2009

Record last verified: 2009-03