Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-27

Study Completion Date

2017-11-25

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Revefenacin

Active Revefenacin and placebo (in place of Spiriva Handihaler®)

Group Type EXPERIMENTAL

Revefenacin

Intervention Type DRUG

Revefenacin administered via nebulization.

Placebo for Spiriva Handihaler®

Intervention Type DRUG

Placebo administered as double blind, double dummy via Spiriva HandiHaler®.

Spiriva Handihaler®

Active Spiriva Handihaler® and placebo (in place of Revefenacin)

Group Type ACTIVE_COMPARATOR

Spiriva Handihaler®

Intervention Type COMBINATION_PRODUCT

Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.

Placebo for Revefenacin

Intervention Type DRUG

Placebo administered as double blind, double dummy via nebulization.

Interventions

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Revefenacin

Revefenacin administered via nebulization.

Intervention Type DRUG

Spiriva Handihaler®

Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.

Intervention Type COMBINATION_PRODUCT

Placebo for Revefenacin

Placebo administered as double blind, double dummy via nebulization.

Intervention Type DRUG

Placebo for Spiriva Handihaler®

Placebo administered as double blind, double dummy via Spiriva HandiHaler®.

Intervention Type DRUG

Other Intervention Names

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TD-4208 Tiotropium

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No