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

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

Outcome

Met primary endpoint

registry p = 0.038; Mean Difference (Net) 56; t-test, 2 sided NCT00680056 ↗

paper FOR-TIO was superior to FOR-PLA in increasing post-treatment FEV(1) and Tlim PMID 20580216 ↗

Publications

• Berton DC, Reis M, Siqueira AC, Barroco AC, Takara LS, Bravo DM, Andreoni S, Neder JA. Effects of tiotropium and formoterol on dynamic hyperinflation and exercise endurance in COPD. Respir Med. 2010 Sep;104(9):1288-96. doi: 10.1016/j.rmed.2010.05.017. Epub 2010 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tiotropium	Other / unclassified	18 ug	Inhaled
Comparator	Formoterol	Other / unclassified	12 ug	Inhaled

Indications