Clinical trial NCT03095456: Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Low Peak Inspiratory Flow Rate (PIFR)
Keywords: Chronic Obstructive Pulmonary Disease, COPD
Low Peak Inspiratory Flow Rate (PIFR)
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2017-03-29
Enrollment: 207
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Trough FEV1 on Day 29
timeFrame: Baseline and Day 29
Secondary outcomes:
measure: Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29
timeFrame: Baseline and Day 29
measure: Change From Baseline Trough Inspiratory Capacity (IC) on Day 29
timeFrame: Baseline and Day 29
measure: Change From Baseline Peak FEV1 on Day 29
timeFrame: Baseline and Day 29 (0-4 hours)
measure: Change From Baseline Peak FVC on Day 29
timeFrame: Baseline and Day 29 (0-4 hours)
measure: Summary of Rescue Medication Use: Puffs Per Day
timeFrame: 1 Month
Other outcomes:
Locations:
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25.
citation: Mahler DA, Ohar JA, Barnes CN, Moran EJ, Pendyala S, Crater GD. Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):321-31. doi: 10.15326/jcopdf.6.4.2019.0137.