drugset / Trial / NCT00680056

Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients

NCT00680056

Phase 4 Completed 33 enrolled Federal University of São Paulo
RandomizedCrossoverQuadruple-blindTreatment

Summary

The primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic obstructive pulmonary disease. The study hypothesis is that combining long acting bronchodilators with different action mechanisms would promote synergistic effects on clinical outcomes.

Timeline

Start
2007-11
Primary completion
2008-12
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tiotropium Other / unclassified 18 ug Inhaled
Comparator Formoterol Other / unclassified 12 ug Inhaled