Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003 and Placebo MDI
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
43
FEV1 AUC0-24 on Day 29
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29
Time frame: Day 29
FEV1 AUC12-24 on Day 29
FEV1 AUC12-24 on Day 29
Time frame: Day 29
FEV1 AUC0-12 on Day 29
FEV1 AUC0-12 on Day 29
Time frame: Day 29
Peak Change From Baseline in FEV1 on Day 29
Peak Change From Baseline in FEV1 following evening Dose on Day 29
Time frame: Day 29
Peak Change From Baseline in FEV1 on Day 29
Peak Change From Baseline in FEV1 following the morning dose on Day 29
Time frame: Day 29
Morning Pre-Dose Trough FEV1 on Day 29
Morning Pre-Dose Trough FEV on Day 29
Time frame: Day 29
Morning Pre-Dose Trough FEV1 on Day 30
Morning Pre-Dose Trough FEV1 on Day 30
Time frame: Day 30
Peak Change From Baseline in Inspiratory Capacity (IC) Following the Evening Dose on Day 29
Peak Change from Baseline in Inspiratory Capacity (IC) following the evening dose on Day 29
Time frame: Day 29
Peak Change From Baseline in IC Following the Morning Dose on Day 29
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Peak Change from Baseline in IC following the morning dose on Day 29
Time frame: Day 29