Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Respiratory COPD O2 Consumption
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 51
Healthy volunteers: no

Brief summary:
A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after administration of Symbicort pMDI 160/4.5 μg.

Detailed description:
Patients with moderate/severe COPD are known to have static hyperinflation and to develop dynamic hyperinflation during exercise. Treatment with inhaled long-acting beta agonists and combination of the long-acting beta agonist (LABA), formoterol and the inhaled corticosteroid, budesonide has been shown to improve IC and decrease lung hyperinflation. In a similar previous pilot single centre study with budesonide/formoterol (Symbicort®) the analysis of cardiac outcomes demonstrated a decrease in maximum volume of oxygen (VO2) compared to placebo. Findings suggested that the use of Symbicort can decrease the cost of breathing and therefore reduce the cardiac demand experienced by COPD patients with hyperinflation at rest. The aim of this study is to investigate whether Symbicort therapy can decrease resting VO2 by decreasing static lung hyperinflation in subjects with COPD and to evaluate changes in cardiac function.

Arms:
arm 1: Symbicort pressurized Metered Dose Inhaler (pMDI) arm 2: Placebo of reference drug

Interventions: intervention 1: Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol intervention 2: Matching Placebo pMDI 160/4.5 μg
Intervention descriptions: intervention 1: Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints intervention 2: Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.

Protocol document: