drugset / Trial / NCT01415518

Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01415518 ↗

Phase 4 Completed 581 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.

Timeline

Start
2011-09-01
Primary completion
2012-12-01
Completion
2012-12-01

Outcome

Met primary endpoint

registry Symbicort Turbuhaler + Ipratropium + Theophylline SR vs Ipratropium + Theophylline SR; p <.0001; Ratio 1.069 (95% CI 1.043 to 1.096); ANCOVA NCT01415518 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject budesonide/formoterol Unknown 4.5 ug Inhaled
Subject budesonide/formoterol Unknown 160 ug Inhaled
Background Ipratropium Small molecule 20 ug Inhaled
Background Theophylline Small molecule 0.1 g Oral