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A 52-week, randomised, double-blind, parallel-group, multi-centre, phase IIIB study comparing the long term safety of SYMBICORTO pMDI 160/4.5 mg x 2 actuations twice daily to budesonide HFA pMDI 160 mg x 2 actuations twice daily in adult/adolescent (greater than or equal to12 years) African American subjects with asthma.

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Trial Profile

A 52-week, randomised, double-blind, parallel-group, multi-centre, phase IIIB study comparing the long term safety of SYMBICORTO pMDI 160/4.5 mg x 2 actuations twice daily to budesonide HFA pMDI 160 mg x 2 actuations twice daily in adult/adolescent (greater than or equal to12 years) African American subjects with asthma.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2022

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At a glance

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

    • Most Recent Events

    • 10 May 2012 Results from this trial published in the Journal of Allergy & Clinical Immunology in May 2012, according to an AstraZeneca media release. Top-line tolerability results were reported also in the media release.
    • 06 Mar 2012 Long-term cardiovascular safety results presented at the 68th Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 27 Oct 2011 Results presented at the 77th Annual Meeting of the American College of Chest Physicians: Chest 2011.

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