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NCT01706328 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
828
Enrollment target
20
Study locations

NCT01706328 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 828 participants, below the 1,033-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT01706328, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
828 participants
Enrollment target
20
Study locations

Study Summary

This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects. Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subject's adherence with study treatment, study procedures and assessment of disease stability. At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period. A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks.

Conditions Studied

Pulmonary Disease, Chronic Obstructive

Interventions

  • DRUG Salbutamol as needed
  • DRUG FF/VI 100/25 Inhalation Powder NDPI
  • DRUG Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS
  • DRUG Placebo Inhalation Powder NDPI
  • DRUG Placebo Inhalation Powder ACCUHALER/DISKUS

Study Locations (20)

South Carolina

  • GSK Investigational Site - Easley
  • GSK Investigational Site - Gaffney
  • GSK Investigational Site - Greenville
  • GSK Investigational Site - Orangeburg
  • GSK Investigational Site - Rock Hill
  • GSK Investigational Site - Seneca
  • GSK Investigational Site - Spartanburg
  • GSK Investigational Site - Union

Hesse

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

Florida

  • GSK Investigational Site - Clearwater
  • GSK Investigational Site - DeLand

Idaho

  • GSK Investigational Site - Coeur d'Alene

Illinois

  • GSK Investigational Site - Normal

Minnesota

  • GSK Investigational Site - Woodbury

North Carolina

  • GSK Investigational Site - Charlotte

Ohio

  • GSK Investigational Site - Columbus

Trial Details

FieldValue
Enrollment Target 828 participants
Start Date 2012-10-15
Est. Completion 2013-06-17
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01706328

The ClinicalTrials.gov registry entry for NCT01706328 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 828 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,033-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (20% 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 5 interventions - of which Salbutamol as needed is the first listed.

NCT01706328 reports 20 study locations spanning 10 distinct geographic areas - top geographies include South Carolina, Hesse, Florida.

Frequently Asked Questions

What is clinical trial NCT01706328 about?

NCT01706328 is a clinical study titled "A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subject...

What is the current status of trial NCT01706328?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 828 participants. The study started on 2012-10-15. Estimated completion is 2013-06-17.

What conditions does trial NCT01706328 study?

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

What interventions are being tested in trial NCT01706328?

The interventions under investigation include: Salbutamol as needed (DRUG), FF/VI 100/25 Inhalation Powder NDPI (DRUG), Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS (DRUG), Placebo Inhalation Powder NDPI (DRUG), Placebo Inhalation Powder ACCUHALER/DISKUS (DRUG).

Who is sponsoring clinical trial NCT01706328?

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

Where is trial NCT01706328 being conducted?

This trial has 20 study locations across Florida, Idaho, Illinois, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.