NCT00646321

Brief Summary

The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years

Trial Health

100
On Track

Trial Health Score

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

Enrollment
540

participants targeted

Target at P50-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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.7 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

January 24, 2011

Status Verified

January 1, 2011

First QC Date

March 26, 2008

Last Update Submit

January 21, 2011

Conditions

Asthma

Keywords

asthmachildrenadolescentsSymbicortbudesonide/ formoterolbudesonide

Outcome Measures

Primary Outcomes (1)

  • Change in evening PEF

    Daily throughout the 12 week treatment period

Secondary Outcomes (2)

  • Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes

    Daily throughout the 12 week treatment period

  • Routine safety assessments described in the protocol

    2-4 assessments within 12 week treatment period

Study Arms (2)

1

EXPERIMENTAL

budesonide/formoterol

Drug: budesonide/formoterol (Symbicort)

2

ACTIVE COMPARATOR

budesonide

Drug: budesonide

Interventions

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

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • At least 6 and maximally 15 years of age
  • Diagnosis of asthma and baseline lung function tests as determined by the protocol
  • Has required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

You may not qualify if:

  • Severe asthma
  • Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Eid NS, Noonan MJ, Chipps B, Parasuraman B, Miller CJ, O'Brien CD. Once- vs twice-daily budesonide/formoterol in 6- to 15-year-old patients with stable asthma. Pediatrics. 2010 Sep;126(3):e565-75. doi: 10.1542/peds.2009-2970. Epub 2010 Aug 16.

    PMID: 20713475DERIVED

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
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 28, 2008

Study Start

April 1, 2003

Study Completion

August 1, 2004

Last Updated

January 24, 2011

Record last verified: 2011-01