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NCT01316900 · ClinicalTrials.gov registry record · Phase 3

24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease

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

Completed
Registry status
Phase 3
Development phase
846
Enrollment target
20
Study locations

NCT01316900 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 846 participants, below the 1,033-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT01316900, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.

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

Study Summary

This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.

Conditions Studied

Pulmonary Disease, Chronic Obstructive

Interventions

  • DRUG GSK573719/GW642444 125/25
  • DRUG GSK573719/GW642444 62.5/25
  • DRUG tiotropium bromide
  • DRUG GW642444

Study Locations (20)

South Carolina

  • GSK Investigational Site - Charleston
  • GSK Investigational Site - Gaffney
  • GSK Investigational Site - Greenville
  • GSK Investigational Site - Rock Hill
  • GSK Investigational Site - Seneca

Florida

  • GSK Investigational Site - DeLand
  • GSK Investigational Site - Orlando
  • GSK Investigational Site - Tampa

Virginia

  • GSK Investigational Site - Newport News
  • GSK Investigational Site - Richmond

Alabama

  • GSK Investigational Site - Birmingham

California

  • GSK Investigational Site - San Diego

Georgia

  • GSK Investigational Site - Decatur

Missouri

  • GSK Investigational Site - Saint Charles

New Mexico

  • GSK Investigational Site - Albuquerque

Trial Details

FieldValue
Enrollment Target 846 participants
Start Date 2011-03-01
Est. Completion 2012-04-24
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 NCT01316900

The ClinicalTrials.gov registry entry for NCT01316900 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 846 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 (18% 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 4 interventions - of which GSK573719/GW642444 125/25 is the first listed.

NCT01316900 reports 20 study locations spanning 13 distinct geographic areas - top geographies include South Carolina, Florida, Virginia.

Frequently Asked Questions

What is clinical trial NCT01316900 about?

NCT01316900 is a clinical study titled "24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease". This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-da...

What is the current status of trial NCT01316900?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 846 participants. The study started on 2011-03-01. Estimated completion is 2012-04-24.

What conditions does trial NCT01316900 study?

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

What interventions are being tested in trial NCT01316900?

The interventions under investigation include: GSK573719/GW642444 125/25 (DRUG), GSK573719/GW642444 62.5/25 (DRUG), tiotropium bromide (DRUG), GW642444 (DRUG).

Who is sponsoring clinical trial NCT01316900?

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

Where is trial NCT01316900 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Missouri. 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.