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
Phase of Trial: Phase III
Latest Information Update: 09 Nov 2017
At a glance
- Drugs Budesonide/formoterol (Primary) ; Formoterol
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Acronyms RISE
- Sponsors AstraZeneca
- 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.