drugset / Trial / NCT01397890

Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01397890

Phase 4 Completed 793 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).

Timeline

Start
2011-07
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 160 ug Inhaled
Subject Formoterol Other / unclassified 4.5 ug Inhaled
Subject Tiotropium Other / unclassified 18 ug Inhaled