Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT01323621 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.

Interventions

  • DRUG Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg
  • DRUG Fluticasone Propionate 250mcg / salmeterol 50mcg
  • DRUG Double-dummy placebo
  • DRUG Salbutamol as needed

Study Locations (20)

South Carolina

  • GSK Investigational Site — Gaffney
  • GSK Investigational Site — Orangeburg
  • GSK Investigational Site — Seneca
  • GSK Investigational Site — Spartanburg

Campania

  • GSK Investigational Site — Naples
  • GSK Investigational Site — San Felice A Cancello Caserta
  • GSK Investigational Site — Telese Terme (BN)

Alabama

  • GSK Investigational Site — Jasper

California

  • GSK Investigational Site — Riverside

Florida

  • GSK Investigational Site — DeLand

Idaho

  • GSK Investigational Site — Coeur d'Alene

Minnesota

  • GSK Investigational Site — Minneapolis

Ohio

  • GSK Investigational Site — Cincinnati

Trial Details

FieldValue
Enrollment Target 512 participants
Start Date 2011-03-18
Est. Completion 2012-01-24
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01323621

The ClinicalTrials.gov registry entry for NCT01323621 describes a study currently listed as completed. It is categorized as Phase 3, 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 512 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 4 interventions — of which Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg 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: NCT01323621 reports 20 study locations spanning 15 distinct geographic areas — top geographies include South Carolina, Campania, Alabama. 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 NCT01323621 about?

NCT01323621 is a clinical study titled "Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.

What is the current status of trial NCT01323621?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 512 participants. The study started on 2011-03-18. Estimated completion is 2012-01-24.

What conditions does trial NCT01323621 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 NCT01323621?

The interventions under investigation include: Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg (DRUG), Fluticasone Propionate 250mcg / salmeterol 50mcg (DRUG), Double-dummy placebo (DRUG), Salbutamol as needed (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01323621?

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 NCT01323621 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Idaho, Minnesota. 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