drugset / Trial / NCT03425617

Effects of Dual Bronchodilator Treatment on Cardiopulmonary Interactions in COPD

NCT03425617

Phase 4 Completed 25 enrolled Queen's University Boehringer Ingelheim · collab
RandomizedCrossoverDouble-blindTreatment

Summary

The deleterious consequences of lung hyperinflation seem not to be restricted to the respiratory system in patients with chronic obstructive pulmonary disease (COPD). Cardiac function, in particular, is strongly influenced by changes in lung volumes and intra-thoracic pressures. In this context, strategies to reduce lung hyperinflation and the work of breathing can positively impact upon cardiac output and blood flow redistribution to peripheral muscles in these patients. There is growing evidence that combination of bronchodilators of different classes is an efficacious and safe strategy for further improving airflow obstruction and hyperinflation in patients with more advanced COPD. Therefore, we aim to investigate that, compared with placebo, a novel LABA/LAMA fixed combination (tiotropium 5 mcg plus olodaterol 5 mcg via Respimat® (Inspiolto®) (TIO/OLO) would decrease lung volumes at rest and during exercise, thereby improving: 1) central and peripheral hemodynamics and 2) arterial oxygenation, with positive consequences on skeletal muscle oxygenation and exercise tolerance in hyperinflated patients with moderate to very severe COPD.

Timeline

Start
2017-01-01
Primary completion
2018-06-30
Completion
2018-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Olodaterol Small molecule 5 ug Inhaled
Subject Tiotropium Other / unclassified 5 ug Inhaled