At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Randomized, Double-blind, Multicenter, Placebo-Controlled Two Way Cross-Over Study to Evaluate Changes in Oxygen Consumption and Cardiac Function in COPD Patients With Resting Hyperinflation After Administration of Symbicort pMDI 160/4.5 μg.
In Brief
A Phase 4 clinical trial evaluating Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol and Matching Placebo pMDI 160/4.5 μg for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 51 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
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
Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.