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NCT02105974 · ClinicalTrials.gov registry record · Phase 3

Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
1,621
Enrollment target

NCT02105974 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,621 participants.

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The verdict

NCT02105974, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
1,621 participants
Enrollment target

Study Summary

This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second \[FEV1\]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.

Interventions

  • DRUG Fluticasone Furoate/Vilanterol
  • DRUG Vilanterol

Trial Details

FieldValue
Enrollment Target 1,621 participants
Start Date 2014-04-07
Est. Completion 2015-07-08
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT02105974

The ClinicalTrials.gov registry entry for NCT02105974 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,621 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Fluticasone Furoate/Vilanterol is the first listed.

NCT02105974 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02105974 about?

NCT02105974 is a clinical study titled "Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary obje...

What is the current status of trial NCT02105974?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,621 participants. The study started on 2014-04-07. Estimated completion is 2015-07-08.

What interventions are being tested in trial NCT02105974?

The interventions under investigation include: Fluticasone Furoate/Vilanterol (DRUG), Vilanterol (DRUG).

Who is sponsoring clinical trial NCT02105974?

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

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

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.