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NCT01573624 · ClinicalTrials.gov registry record · Phase 2

Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma

A Phase 2 study of Asthma, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
421
Enrollment target
20
Study locations

NCT01573624 is a Phase 2 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 421 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT01573624, a Phase 2 study of Asthma, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
421 participants
Enrollment target
20
Study locations

Study Summary

Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control. Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.

Conditions Studied

Asthma

Interventions

  • DRUG FF/GSK573719

Study Locations (20)

Other

  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Mendoza
  • GSK Investigational Site - San Miguel de Tucumán
  • GSK Investigational Site - San Miguel de Tucumán
  • GSK Investigational Site - Santiago
  • GSK Investigational Site - Barnaul
  • GSK Investigational Site - Kazan'
  • GSK Investigational Site - Klin

Región Metro de Santiago

  • GSK Investigational Site - Puente Alto - Santiago
  • GSK Investigational Site - Santiago
  • GSK Investigational Site - Santiago
  • GSK Investigational Site - Santiago
  • GSK Investigational Site - Talca

South Carolina

  • GSK Investigational Site - Orangeburg
  • GSK Investigational Site - Spartanburg

Missouri

  • GSK Investigational Site - St Louis

Oregon

  • GSK Investigational Site - Medford

Región de Valparaíso

  • GSK Investigational Site - Valparaíso

Trial Details

FieldValue
Enrollment Target 421 participants
Start Date 2012-04-03
Est. Completion 2013-02-04
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01573624

The ClinicalTrials.gov registry entry for NCT01573624 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 421 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (73% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which FF/GSK573719 is the first listed.

NCT01573624 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, Región Metro de Santiago, South Carolina.

Frequently Asked Questions

What is clinical trial NCT01573624 about?

NCT01573624 is a clinical study titled "Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma". Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control. Detailed Description: L...

What is the current status of trial NCT01573624?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 421 participants. The study started on 2012-04-03. Estimated completion is 2013-02-04.

What conditions does trial NCT01573624 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT01573624?

The interventions under investigation include: FF/GSK573719 (DRUG).

Who is sponsoring clinical trial NCT01573624?

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

Where is trial NCT01573624 being conducted?

This trial has 20 study locations across Missouri, Oregon, South Carolina, Región de Valparaíso, Región Metro de Santiago. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.