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NCT01957150 · ClinicalTrials.gov registry record · Phase 4

Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

A Phase 4 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
283
Enrollment target

NCT01957150 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 283 participants.

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The verdict

NCT01957150, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
283 participants
Enrollment target

Study Summary

This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.

Interventions

  • DRUG Fluticasone Furoate/Vilanterol
  • DRUG Vilanterol

Trial Details

FieldValue
Enrollment Target 283 participants
Start Date 2014-01-28
Est. Completion 2018-03-26
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01957150

The ClinicalTrials.gov registry entry for NCT01957150 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 283 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.

NCT01957150 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01957150 about?

NCT01957150 is a clinical study titled "Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).". This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on...

What is the current status of trial NCT01957150?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 283 participants. The study started on 2014-01-28. Estimated completion is 2018-03-26.

What interventions are being tested in trial NCT01957150?

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

Who is sponsoring clinical trial NCT01957150?

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.