To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Glycopyrronium
Formoterol Fumarate
Research Site
Edegem, Belgium
Research Site
Erpent, Belgium
Specific Image-Based Airway Volume (siVaw)
Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline
Time frame: Baseline, Day 15
Specific Image-based Airway Resistance (siRaw)
Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.
Time frame: Baseline, Day 15
Image-based Airway Volume (iVaw)
Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline.
Time frame: Baseline, Day 15
Image-based Airway Resistance (iRaw)
Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline.
Time frame: Baseline, Day 15
FEV1
FEV1 Change from baseline in Forced Expiratory Volume at 1 second.
Time frame: Baseline, Day 15
Functional Residual Capacity (FRC)
Functional residual capacity (FRC). Ratio to baseline.
Time frame: Baseline, Day 15
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