This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF), and Glycopyrronium/Formoterol Fumarate (GFF), on specific image based airway volumes and resistance in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. In this study, airway dimension parameters will be calculated for each of the active compounds. This imaging methodology will allow an assessment of the extent of airway changes using a triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual combination Glycopyrronium/Formoterol Fumarate (GFF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
Research Site
Erpent, Belgium
Research Site
Eindhoven, Netherlands
Research Site
Groningen, Netherlands
Research Site
Zutphen, Netherlands
Specific Image-based Airway Volume (siVaw)
Specific image-based airway volume (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
Time frame: Baseline, Day 29
Specific Image-based Airway Resistance (siRaw)
Specific image-based airway resistance (siRaw) measured in kPa∙s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
Time frame: Baseline, Day 29
Image-based Airway Volume (iVaw)
Image-based Airway Volume (iVaw) measured in mL. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.
Time frame: Baseline, Day 29
Image-based Airway Resistance (iRaw)
Image-based airway resistance (iRaw) measured in kPa∙s/L. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.
Time frame: Baseline, 29 Days
Forced Expiratory Volume in One Second (Post-dose FEV1).
Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1).
Time frame: Baseline 29 Days
Functional Residual Capacity (FRC)
Change from baseline in Functional residual capacity (FRC).
Time frame: Baseline, Day 29
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