CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 207 enrolled
Drug / intervention
Revefenacin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03095456
NCT03095456Phase 3Completed
CompareCT.gov

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

Mylan Inc.·interventional·Posted Mar 29, 2017·Updated Feb 24, 2022

In Brief

A Phase 3 clinical trial evaluating Revefenacin, Spiriva Handihaler®, and 2 other interventions for Chronic Obstructive Pulmonary Disease, COPD and Low Peak Inspiratory Flow Rate (PIFR). Completed, enrolled 207 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)
CountriesUnited States
CollaboratorsTheravance Biopharma

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 29, 2017
Enrollment StartMar 27, 2017
Primary CompletionNov 25, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.3 years ago

Interventions

Revefenacindrug

Revefenacin administered via nebulization.

Spiriva Handihaler®combination

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

Placebo for Revefenacindrug

Placebo administered as double blind, double dummy via nebulization.

Placebo for Spiriva Handihaler®drug

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