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NCT02799784 · ClinicalTrials.gov registry record · Phase 4

An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients

A Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
236
Enrollment target
20
Study locations

NCT02799784 is a Phase 4 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 236 participants, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT02799784, a Phase 4 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
236 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to assess the effect of umeclidinium/vilanterol (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD. This is a multicentre, randomized, open label, 2 period crossover complete block design study. Eligible subjects, who complete a 2-week run-in period, will be randomized to receive a sequence consisting of UMEC/VI inhalation powder (62.5/25 microgram \[mcg\] once-daily \[QD\]) administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray administered as 2 inhalations via the RESPIMAT® inhaler, for 8 weeks each. This will be followed by a 3-week washout period and one-week follow-up period. The total duration of subject participation in the study will be approximately 22 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies. RESPIMAT is a registered trademark of Boehringer Ingelheim.

Conditions Studied

Pulmonary Disease, Chronic Obstructive

Interventions

  • DRUG UMEC/VI
  • DRUG TIO/OLO
  • DRUG Albuterol/salbutamol

Study Locations (20)

South Carolina

  • GSK Investigational Site - Charleston
  • GSK Investigational Site - Greenville
  • GSK Investigational Site - Spartanburg

Hesse

  • GSK Investigational Site - Frankfurt am Main
  • GSK Investigational Site - Frankfurt am Main
  • GSK Investigational Site - Neu-Isenburg

Other

  • GSK Investigational Site - Magdeburg
  • GSK Investigational Site - Alicante
  • GSK Investigational Site - Girona

Florida

  • GSK Investigational Site - Clearwater
  • GSK Investigational Site - Orlando

Saxony

  • GSK Investigational Site - Dresden
  • GSK Investigational Site - Leipzig

Missouri

  • GSK Investigational Site - St Louis

Oregon

  • GSK Investigational Site - Medford

Virginia

  • GSK Investigational Site - Richmond

Trial Details

FieldValue
Enrollment Target 236 participants
Start Date 2016-07-14
Est. Completion 2017-04-27
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT02799784

The ClinicalTrials.gov registry entry for NCT02799784 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (77% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which UMEC/VI is the first listed.

NCT02799784 reports 20 study locations spanning 12 distinct geographic areas - top geographies include South Carolina, Hesse, Other.

Frequently Asked Questions

What is clinical trial NCT02799784 about?

NCT02799784 is a clinical study titled "An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients". The primary objective of this study is to assess the effect of umeclidinium/vilanterol (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD. This is a multicentre, randomized, open label, 2 period crossover complete block design study. Eligible subjects, who complete a ...

What is the current status of trial NCT02799784?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 236 participants. The study started on 2016-07-14. Estimated completion is 2017-04-27.

What conditions does trial NCT02799784 study?

This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.

What interventions are being tested in trial NCT02799784?

The interventions under investigation include: UMEC/VI (DRUG), TIO/OLO (DRUG), Albuterol/salbutamol (DRUG).

Who is sponsoring clinical trial NCT02799784?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02799784 being conducted?

This trial has 20 study locations across Florida, Missouri, Oregon, South Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.