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Randomized, Open-label, Crossover Clinical Trial to Assess the Effects of Indacaterol 150 µg d.o. Compared to Tiotropium Bromide 5 µg d.o. on Dyspnea, Dynamic Pulmonary Hyperinflation and Exercise Tolerance in Patients With Moderate COPD
Exercise intolerance is a major complain of patients with chronic obstructive pulmonary disease (COPD). Dynamic hyperinflation has been recognized as an important limiting factor responsible for the appearance of intolerable dyspnea during exercise. Regular treatment with long-acting bronchodilators promotes a more sustained reduction of hyperinflation and consequent symptom relief and increase in the patient's ability to overcome physical demands of daily life. Tiotropium bromide (TIO) is a new generation, long-acting anticholinergic bronchodilator that significantly improves lung function, reduces symptoms and improves exercise tolerance in patients with advanced COPD. Indacaterol is a new ultra-long duration (\>24 h) β2-agonist, which promotes sustained dilation of the bronchi with a once-daily administration. Compared to tiotropium, indacaterol provides evidence that is as effective as tiotropium for bronchodilation, as well as other clinical outcomes such as dyspnea and state of health. However, comparative effects of indacaterol versus tiotropium with regard to outcomes in tolerance, dyspnea and dynamic lung hyperinflation during exercise is scarce. We hypothesized that indacaterol and TIO are not different in terms of exercise tolerance and its determinants (dynamic hyperinflation and dyspnea).
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Pavilhão Pereira Filho
Porto Alegre, Rio Grande do Sul, Brazil
Pavilhão Pereira Filho
Porto Alegre, Rio Grande do Sul, Brazil
Start Date
March 1, 2013
Primary Completion Date
October 1, 2013
Completion Date
October 1, 2013
Last Updated
January 8, 2014
20
ACTUAL participants
Indacaterol
DRUG
Tiotropium
DRUG
Lead Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
Collaborators
NCT07477600
NCT05878769
NCT06717659
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