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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed

Conditions Studied

Pulmonary Disease, Chronic Obstructive

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
GlaxoSmithKline

1,345 total trials

What the finished NCT01772134 record still lists

NCT01772134 is an interventional study that assigns participants to a tested intervention. The registered 617 participants enrollment target is mid-sized for trials with a published cap, below the 1,036-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (40% lower).

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 names 20 study sites across 15 states, led by 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.

Learn More About Clinical Trials

Similar trials for Pulmonary Disease, Chronic Obstructive

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01772134's enrollment target sits among peer trials

617 24th of 74 higher than 51 of 74 other Pulmonary Disease, Chronic Obstructive trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01772134, the US trial registry maintained by the National Library of Medicine. NCT01772134 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.