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The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Symptoms on Tiotropium

NCT01899742 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 497

Last updated 2018-01-24

Study results available
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Summary

The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Umeclidinium/Vilanterol 62.5/25 mcg

Inhalation Powder

DRUG

Tiotropium 18 mcg

Inhalation Powder

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-15
Primary Completion
2015-07-22
Completion
2015-07-22

Countries

  • United States
  • Argentina
  • Estonia
  • Germany
  • Norway
  • Russia
  • South Africa
  • South Korea
  • Sweden
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

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 NCT01899742 on ClinicalTrials.gov