Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
Status: | Completed |
---|---|
Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 2/14/2019 |
Start Date: | March 27, 2017 |
End Date: | November 25, 2017 |
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
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.
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.
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.
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