Randomized, Phase IIIb, Three-period, Three-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, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24
Normalized Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-24
Time frame: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29
FEV1 AUC12-24
Normalized FEV1 AUC12-24
Time frame: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29
FEV1 AUC0-12
Normalized FEV1 AUC0-12
Time frame: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29
Peak Change From Baseline in FEV1 Evening
Peak Change From Baseline in FEV1 Evening
Time frame: Baseline and Day 29
Peak Change From Baseline in FEV1 Morning
Peak Change From Baseline in FEV1 Morning
Time frame: Baseline and Day 29
Morning Pre-Dose Trough FEV1 on Day 29
Morning Pre-Dose Trough FEV1 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 IC (Inspiratory Capacity) Evening
Peak Change From Baseline in IC Evening
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Time frame: Baseline and Day 29
Peak Change From Baseline in IC Morning
Peak Change From Baseline in IC Morning
Time frame: Baseline and Day 29