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COMPLETED Phase 2

Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component

NCT02164539 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.

Interventions

  • DRUG FF
  • DRUG UMEC
  • DRUG VI

Study Locations (20)

South Carolina

  • GSK Investigational Site — Gaffney
  • GSK Investigational Site — Greenville
  • GSK Investigational Site — Rock Hill
  • GSK Investigational Site — Spartanburg
  • GSK Investigational Site — Union

California

  • GSK Investigational Site — Newport Beach
  • GSK Investigational Site — San Diego
  • GSK Investigational Site — Upland

Other

  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Mendoza

Louisiana

  • GSK Investigational Site — Sunset

Minnesota

  • GSK Investigational Site — Minneapolis

North Carolina

  • GSK Investigational Site — Charlotte

Ohio

  • GSK Investigational Site — Cincinnati

Oregon

  • GSK Investigational Site — Medford

Trial Details

FieldValue
Enrollment Target 338 participants
Start Date 2014-07-01
Est. Completion 2015-07-18
Phase Phase 2

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02164539

The ClinicalTrials.gov registry entry for NCT02164539 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 338 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions — of which FF is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02164539 reports 20 study locations spanning 13 distinct geographic areas — top geographies include South Carolina, California, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02164539 about?

NCT02164539 is a clinical study titled "Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component". The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium ...

What is the current status of trial NCT02164539?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 338 participants. The study started on 2014-07-01. Estimated completion is 2015-07-18.

What conditions does trial NCT02164539 study?

This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02164539?

The interventions under investigation include: FF (DRUG), UMEC (DRUG), VI (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02164539?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02164539 being conducted?

This trial has 20 study locations across California, Louisiana, Minnesota, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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