Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

Mylan

Status and phase: Completed; Phase 3

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

Treatments: Drug: Placebo for Revefenacin; Drug: Revefenacin; Drug: Placebo for Spiriva Handihaler®; Combination Product: Spiriva Handihaler®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03095456

0149

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups

Revefenacin

Experimental group

Description:

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

Treatment:

Drug: Revefenacin

Drug: Placebo for Spiriva Handihaler®

Spiriva Handihaler®

Active Comparator group

Description:

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

Treatment:

Combination Product: Spiriva Handihaler®

Drug: Placebo for Revefenacin