drugset / Trial / NCT00821093

Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)

NCT00821093 ↗

Phase 3 Completed 1123 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.

Timeline

Start
2009-01
Primary completion
2009-10
Completion
2009-10

Outcome

Met primary endpoint

paper At Week 12, FEV(1) AUC(5 min-11 h 45 min) for indacaterol was statistically superior (p<0.001) to salmeterol PMID 21367594 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Indacaterol Other / unclassified 150 ug Inhaled
Comparator Salmeterol Other / unclassified 50 ug Inhaled