Effects of Dual Bronchodilator Treatment on Cardiopulmonary Interactions in COPD (NCT03425617) | Clinical Trial Compass
CompletedPhase 4
Effects of Dual Bronchodilator Treatment on Cardiopulmonary Interactions in COPD
Canada25 participantsStarted 2017-01-01
Plain-language 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.
Who can participate
Age range50 Years – 100 Years
SexALL
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Inclusion criteria
✓. Age ≥50 years;
✓. Male or female gender;
✓. Long-term history of active smoking;
✓. Signs and symptoms of COPD with adequate treatment according to the GOLD recommendations for at least 3 months (1);
✓. A modified MRC dyspnea score ≥2 or a Baseline Dyspnea Index ≤8;
✓. Resting lung hyperinflation as demonstrated by inspiratory capacity \<80% predicted or functional residual capacity \>120% predicted at Visit 1;
✓. Objective evidence of dynamic hyperinflation (a decrease in inspiratory capacity from rest \>200 mL)(24,25) and peak exercise dyspnea (breathing discomfort) ≥ leg discomfort scores during the incremental cardiopulmonary exercise test at Visit 1;
✓. A positive "volume" response (≥200 mL increase in inspiratory capacity) to a bronchodilator (400μg salbutamol) at Visit 1
Exclusion criteria
✕. Asthma or other concomitant pulmonary disease;