Status:

COMPLETED

Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT

Lead Sponsor:

AstraZeneca

Conditions:

Asthma

Eligibility:

All Genders

6-15 years

Phase:

PHASE3

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

April 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2004

Estimated Enrollment :

540 Patients enrolled

Trial Details

Trial ID

NCT00646321

Start Date

April 1 2003

End Date

August 1 2004

Last Update

January 24 2011

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