NCT00651547

Brief Summary

The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in 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
405

participants targeted

Target at P50-P75 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

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

March 30, 2009

Status Verified

March 1, 2009

First QC Date

April 1, 2008

Last Update Submit

March 27, 2009

Conditions

Asthma

Keywords

AsthmaSymbicortbudesonide/formoterolbudesonideformoterolchildren

Outcome Measures

Primary Outcomes (1)

  • Morning PEF

    Daily

Secondary Outcomes (1)

  • Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments

    Throughout the treatment period

Study Arms (3)

1

EXPERIMENTAL
Drug: budesonide/formoterol

2

ACTIVE COMPARATOR
Drug: budesonide

3

ACTIVE COMPARATOR
Drug: formoterol

Interventions

budesonide/formoterolDRUG
Also known as: Symbicort
1
budesonideDRUG
2
formoterolDRUG
3

Eligibility Criteria

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

You may qualify if:

  • Baseline lung function tests results as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

You may not qualify if:

  • Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
  • Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
  • Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug CombinationBudesonideFormoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Catherine Bonuccelli

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 3, 2008

Study Start

July 1, 2002

Study Completion

October 1, 2003

Last Updated

March 30, 2009

Record last verified: 2009-03