This study is a phase III clinical study to assess the efficacy and safety of Revefenacin inhalation solution 175 mcg administered once daily via nebulization for 12 weeks compared to placebo in a population of Chinese subjects with moderate to very severe COPD.
This will be a multi-center, randomized, double blind, placebo-controlled, parallel group study, randomizing approximately 320 male or female moderate-very severe COPD subjects. Subjects will receive study drug for 12 weeks. Treatments to be received during the study will include one of the following, administered using a centrally-provided, standard jet nebulizer and compressor via a mouthpiece: A. Revefenacin inhalation solution 175 mcg Quaque die (QD). B. Placebo inhalation solution QD. Subjects will have approximately 6 clinic visits (encompassing a screening period of up to 30 days and a treatment period of 12 weeks), and a follow-up telephone call 1-2 weeks after the End of Treatment (EoT) visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
258
Revefenacin
Placebo
Trough FEV1 on Day 85
Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85
Time frame: Baseline and Day 85
Trough FEV1 on Day 85 - Sensitivity Analysis With Missing Data Imputed
Sensitivity analysis results of change from baseline in trough FEV1 (mL) on Day 85 with missing data imputed by last observation carried forward
Time frame: Baseline, Day 29, Day 57 and Day 85
Trough FVC on Day 85
Change from baseline (Day 1, pre-dose) trough Forced Vital Capacity (FVC) on Day 85
Time frame: Baseline and Day 85
Change From Baseline in Peak FEV1 (0-2h) on Day 1
Baseline FEV1 was defined as the average of the -45 and -15 minute measurements prior to dosing of study drug on Day 1. Peak FEV1 (0-2h) was defined as the highest post dose FEV1 value within 2 hours after the dosing.
Time frame: Day 1, from 45 minutes before dosing to 2 hours after dosing
Change From Baseline in Peak FEV1 (0-2h) on Day 85
Baseline FEV1 was defined as the average of the -45 and -15 minute measurements prior to dosing of study drug on Day 1. Peak FEV1 (0-2h) was defined as the highest post dose FEV1 value within 2 hours after the dosing.
Time frame: Day 1 (baseline) and Day 85, from 45 minutes before dosing to 2 hours after dosing
Change From Baseline in SGRQ Total Score on Day 85
Change from Baseline in the St George's Respiratory Questionnaire (SGRQ) Total Score on Day 85. Scores range from 0 to 100, with higher scores indicating more health limitations. A reduction of 4 or more points is considered to be a clinically meaningful improvement
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Anhui Medical University - Hefei First People's Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
The Third Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Second Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Gunagdong, China
Hainan General Hospital
Haikou, Hainan, China
The First Hospital of Changsha
Changsha, Hunan, China
...and 25 more locations
Time frame: Day 1 (baseline) and Day 85
Number (%) of SGRQ Responders on Day 85
Number of subjects with a decrease from baseline of ≥4 units in SGRQ total score (which was defined as a responder) on Day 85
Time frame: Day 85