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NCT01772134 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of the Addition of Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide (62.5 or 125mcg) Once-daily Over 12 Weeks

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

Completed
Registry status
Phase 3
Development phase
617
Enrollment target
20
Study locations

NCT01772134 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 617 participants, below the 1,036-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT01772134, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.

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

Study Summary

The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Interventions

  • DRUG Placebo
  • DRUG Umeclidinium bromide 62.5mcg
  • DRUG Umeclidinium bromide 125mcg
  • DRUG Fluticasone propionate 250mcg/Salmeterol 50mcg

Study Locations (20)

South Carolina

  • GSK Investigational Site - Easley
  • GSK Investigational Site - Greenville
  • GSK Investigational Site - Union

Ontario

  • GSK Investigational Site - Burlington
  • GSK Investigational Site - Greater Sudbury
  • GSK Investigational Site - Sarnia

Florida

  • GSK Investigational Site - Clearwater
  • GSK Investigational Site - Ormond Beach

Alabama

  • GSK Investigational Site - Jasper

Indiana

  • GSK Investigational Site - Lafayette

Louisiana

  • GSK Investigational Site - New Orleans

Minnesota

  • GSK Investigational Site - Edina

Missouri

  • GSK Investigational Site - St Louis

Trial Details

FieldValue
Enrollment Target 617 participants
Start Date 2013-01-01
Est. Completion 2013-07-22
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01772134

The ClinicalTrials.gov registry entry for NCT01772134 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 617 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,036-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (40% 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 Placebo is the first listed.

NCT01772134 reports 20 study locations spanning 15 distinct geographic areas - top geographies include South Carolina, Ontario, Florida.

Frequently Asked Questions

What is clinical trial NCT01772134 about?

NCT01772134 is a clinical study titled "Efficacy and Safety of the Addition of Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide (62.5 or 125mcg) Once-daily Over 12 Weeks". The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo t...

What is the current status of trial NCT01772134?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2013-01-01. Estimated completion is 2013-07-22.

What conditions does trial NCT01772134 study?

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

What interventions are being tested in trial NCT01772134?

The interventions under investigation include: Placebo (DRUG), Umeclidinium bromide 62.5mcg (DRUG), Umeclidinium bromide 125mcg (DRUG), Fluticasone propionate 250mcg/Salmeterol 50mcg (DRUG).

Who is sponsoring clinical trial NCT01772134?

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

Where is trial NCT01772134 being conducted?

This trial has 20 study locations across Alabama, Florida, Indiana, Louisiana, Minnesota. 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.