Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance With Moderate to Severe COPD.
Enrolled patients with COPD who were randomized to receive either PT003 MDI or Placebo MDI first and then crossed over to receive the opposite intervention. The study consisted of 2 treatment periods of 14 days separated by a washout period of 5-21 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Glycopyrronium and Formoterol Fumarate
Comparator: Placebo MDI which contains no active ingredients
Research Site
Edegem, Belgium
Specific Airway Volume (siVaw)
Specific image-based airway volume. Average across lobe, adjusted for lobe volume
Time frame: Day 15
Specific Airway Resistance (siRaw)
Specific image-based airway resistance. Average across lobes, adjusted for lobe volume
Time frame: Day 15
Airway Resistance (iRaw)
iRaw represents the airway resistance, averaged across lobes, without correction for lung lobe volume
Time frame: Day 15
Airway Volume (iVaw)
iVaw represents the airway Volume, averaged across lobes, without correction for lung lobe volume
Time frame: Day 15
Change From Baseline in FEV1 (L) at Day 15
Change from baseline in Forced Expiratory Volume at 1 second
Time frame: Baseline and Day 15
Change From Baseline in FRC (L) at Day 15
Change from baseline in Functional Residual Capacity
Time frame: Baseline and Day 15
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