Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3b, 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 PIFR

Conditions
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Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)

Intervention / Treatment
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* Drug: Revefenacin
* Combination Product: Spiriva Handihaler®
* Drug: Placebo for Revefenacin
* Drug: Placebo for Spiriva Handihaler®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a male or female subject 40 years of age or older with a diagnosis of COPD. Subject has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years. Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures. Exclusion Criteria: Subject has a concurrent disease or condition that, in the opinion of the investigator, would interfere with continued study participation or confound the evaluation of safety and tolerability of the study drug. Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics. Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revefenacin<br>Active Revefenacin and placebo (in place of Spiriva Handihaler®) | Drug: Revefenacin<br>* Revefenacin administered via nebulization.<br>* Other names: TD-4208;Drug: Placebo for Spiriva Handihaler®<br>* Placebo administered as double blind, double dummy via Spiriva HandiHaler®.<br>|
| Active Comparator: Spiriva Handihaler®<br>Active Spiriva Handihaler® and placebo (in place of Revefenacin) | Combination Product: Spiriva Handihaler®<br>* Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.<br>* Other names: Tiotropium;Drug: Placebo for Revefenacin<br>* Placebo administered as double blind, double dummy via nebulization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough FEV1 on Day 29 | FEV1 = forced expiratory volume at one second | Baseline and Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29 |  | Baseline and Day 29 | 
| Change From Baseline Trough Inspiratory Capacity (IC) on Day 29 |  | Baseline and Day 29 | 
| Change From Baseline Peak FEV1 on Day 29 |  | Baseline and Day 29 (0-4 hours) | 
| Change From Baseline Peak FVC on Day 29 |  | Baseline and Day 29 (0-4 hours) | 
| Summary of Rescue Medication Use: Puffs Per Day |  | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)