drugset / Trial / NCT00845728

Exacerbation Study

NCT00845728 ↗

Phase 3 Completed 3439 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

Timeline

Start
2009-03
Primary completion
2012-07
Completion
2012-07

Outcome

Met primary endpoint

paper The lower limit of the 97.5% CI was above the prespecified non-inferiority margin of -0.055 L, suggesting that indacaterol was non-inferior to tiotropium. PMID 24461613 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Indacaterol Other / unclassified 150 ug Inhaled
Comparator Tiotropium Other / unclassified 18 ug Inhaled