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A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort Pressurized Metered-Dose Inhaler (pMDI) 160/4.5 mcg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 mcg x 2 Inhalations Twice-daily in Cronic Obstructive Pulmonary Disease (COPD) Patients

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Trial Profile

A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort Pressurized Metered-Dose Inhaler (pMDI) 160/4.5 mcg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 mcg x 2 Inhalations Twice-daily in Cronic Obstructive Pulmonary Disease (COPD) Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Oct 2021

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At a glance

  • Drugs Budesonide/formoterol (Primary) ; Formoterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms RISE
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 01 Nov 2017 Results (n=1219) assessing effect of budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus formoterol dry powder inhaler (DPI) on reducing COPD exacerbations, were published in the Respiratory Medicine.
  • 10 Aug 2016 Primary endpoint (The rate of moderate and severe COPD exacerbations defined as: Worsening of 2 major symptoms or worsening of 1 major symptom together with 1 minor symptom for 2 consecutive days) has been met, according to an AstraZeneca media release.
  • 07 Mar 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.

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