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A 4-week, open-label, randomized, multi-centre, parallel-group study evaluating the safety and efficacy of 4 actuations symbicort (budesonide/formoterol) HFA pMDI [hydrofluoroalkane pressurised metered-dose inhaler] 40/2.25 microg twice daily, with and without spacer, in children (6-11 years) with asthma.

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Trial Profile

A 4-week, open-label, randomized, multi-centre, parallel-group study evaluating the safety and efficacy of 4 actuations symbicort (budesonide/formoterol) HFA pMDI [hydrofluoroalkane pressurised metered-dose inhaler] 40/2.25 microg twice daily, with and without spacer, in children (6-11 years) with asthma.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Budesonide/formoterol (Primary)
  • Indications Asthma
  • Focus Adverse reactions
  • Sponsors AstraZeneca

    • Most Recent Events

    • 15 Mar 2012 Actual initiation data changed from Sep 2007 to 15 Aug 2007 as reported by European Clinical Trials Database.
    • 04 Jun 2008 Astrazeneca submitted sNDA to FDA for the long-term maintenace of asthma in children 6-11 years of age.
    • 31 Mar 2008 Status change from in progress to completed, according to clinicaltrials.gov.

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