Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

• Status: Completed
• Trial end date: 2017-11-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.; Theravance Biopharma R & D, Inc.
• Collaborator: Theravance Biopharma
• Treatments: Tiotropium Bromide

Criteria

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.