A randomised, double-blind, double dummy, multicentre phase III study comparing the efficacy of budesonide/formoterol (Symbicort (R) Forte Turbuhaler (R)) and oral prednisolone + formoterol (Oxis (R) Turbuhaler) during two weeks, in COPD [chronic obstructive pulmonary disease] patients with an acute exacerbation, followed by twelve weeks open follow up period with budesonide/formoterol (Symbicort Forte Turbuhaler)

Trial Profile

A randomised, double-blind, double dummy, multicentre phase III study comparing the efficacy of budesonide/formoterol (Symbicort (R) Forte Turbuhaler (R)) and oral prednisolone + formoterol (Oxis (R) Turbuhaler) during two weeks, in COPD [chronic obstructive pulmonary disease] patients with an acute exacerbation, followed by twelve weeks open follow up period with budesonide/formoterol (Symbicort Forte Turbuhaler)

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Budesonide/formoterol (Primary) ; Formoterol; Prednisolone
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms SPACE
  • Sponsors AstraZeneca
  • Most Recent Events

    • 07 Oct 2008 Primary endpoint 'Forced expiratory volume in 1 second' has been met.
    • 07 Oct 2008 Results reported at Annual Congress of European Respiratory Scoiety.
    • 11 Jan 2008 Status changed from in progress to completed as reported by ClinicalTrials.gov.
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