This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
207
Revefenacin administered via nebulization.
Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo administered as double blind, double dummy via nebulization.
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Change From Baseline in Trough FEV1 on Day 29
FEV1 = forced expiratory volume at one second
Time frame: Baseline and Day 29
Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29
Time frame: Baseline and Day 29
Change From Baseline Trough Inspiratory Capacity (IC) on Day 29
Time frame: Baseline and Day 29
Change From Baseline Peak FEV1 on Day 29
Time frame: Baseline and Day 29 (0-4 hours)
Change From Baseline Peak FVC on Day 29
Time frame: Baseline and Day 29 (0-4 hours)
Summary of Rescue Medication Use: Puffs Per Day
Time frame: 1 Month
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Placebo administered as double blind, double dummy via Spiriva HandiHaler®.