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Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

NCT03095456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2022-02-24

Study results available
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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.

Conditions

  • Chronic Obstructive Pulmonary Disease, COPD
  • Low Peak Inspiratory Flow Rate (PIFR)

Interventions

DRUG

Revefenacin

Revefenacin administered via nebulization.

COMBINATION_PRODUCT

Spiriva Handihaler®

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

DRUG

Placebo for Revefenacin

Placebo administered as double blind, double dummy via nebulization.

DRUG

Placebo for Spiriva Handihaler®

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

Sponsors & Collaborators

  • Theravance Biopharma

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2017-11-25
Completion
2017-11-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095456 on ClinicalTrials.gov