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NCT03227445 · ClinicalTrials.gov registry record · Phase 4

Comparative Study of ELLIPTA Dry Powder Inhaler (DPI) Versus DISKUS DPI Used With HandiHaler DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
240
Enrollment target
18
Study locations

NCT03227445 is a Phase 4 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 240 participants, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (77% lower). The trial reports 18 study locations across 9 states.

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The verdict

NCT03227445, a Phase 4 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
240 participants
Enrollment target
18
Study locations

Study Summary

This randomized, cross over study aims to find out the benefits of delivering triple therapy using a single ELLIPTA® DPI (fixed-dose combination triple therapy) versus delivering triple therapy using two different types of inhalers (open triple therapy) including DISKUS® with HandiHaler® to subjects with COPD. Correct inhaler use, critical errors and performance attributes will also be assessed. Approximately 240 subjects with COPD will be randomized in the study. The study will be conducted in 3 visits and will be completed in approximately 56 days. At Visit 1 (Day 1) and Visit 2 (Day 28) subjects will be randomized to receive a placebo ELLIPTA inhaler once daily (QD) or a placebo DISKUS twice daily (BID) with placebo HandiHaler QD inhaler in 1:1 ratio in a cross-over manner for the study period (28 days for each period). At Visit 3 (Day 56), subjects will be asked to complete preference questionnaire 1 or 2. There will be no active treatment and subjects will continue to take their own prescribed COPD maintenance and rescue medication during the entire study period. ELLIPTA and DISKUS are the registered trademarks of GlaxoSmithKline group of companies. HandiHaler is the registered trademark of Boehringer Ingelheim group of companies.

Conditions Studied

Pulmonary Disease, Chronic Obstructive

Interventions

  • DEVICE ELLIPTA placebo DPI
  • DEVICE DISKUS placebo DPI
  • DEVICE HandiHaler placebo DPI
  • OTHER Inhaler preference questionnaires

Study Locations (18)

North Carolina

  • GSK Investigational Site - Charlotte
  • GSK Investigational Site - Gastonia
  • GSK Investigational Site - Monroe
  • GSK Investigational Site - Mooresville

South Carolina

  • GSK Investigational Site - Anderson
  • GSK Investigational Site - Greenville
  • GSK Investigational Site - Rock Hill
  • GSK Investigational Site - Spartanburg

Ohio

  • GSK Investigational Site - Canton
  • GSK Investigational Site - Cincinnati
  • GSK Investigational Site - Dayton

Virginia

  • GSK Investigational Site - Richmond
  • GSK Investigational Site - Richmond

Florida

  • GSK Investigational Site - Orlando

Louisiana

  • GSK Investigational Site - Natchitoches

Missouri

  • GSK Investigational Site - Saint Charles

Oklahoma

  • GSK Investigational Site - Oklahoma City

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2017-09-20
Est. Completion 2018-01-04
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03227445

The ClinicalTrials.gov registry entry for NCT03227445 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (77% 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 ELLIPTA placebo DPI is the first listed.

NCT03227445 reports 18 study locations spanning 9 distinct geographic areas - top geographies include North Carolina, South Carolina, Ohio.

Frequently Asked Questions

What is clinical trial NCT03227445 about?

NCT03227445 is a clinical study titled "Comparative Study of ELLIPTA Dry Powder Inhaler (DPI) Versus DISKUS DPI Used With HandiHaler DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This randomized, cross over study aims to find out the benefits of delivering triple therapy using a single ELLIPTA® DPI (fixed-dose combination triple therapy) versus delivering triple therapy using two different types of inhalers (open triple therapy) including DISKUS® with HandiHaler® to subjects...

What is the current status of trial NCT03227445?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 240 participants. The study started on 2017-09-20. Estimated completion is 2018-01-04.

What conditions does trial NCT03227445 study?

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

What interventions are being tested in trial NCT03227445?

The interventions under investigation include: ELLIPTA placebo DPI (DEVICE), DISKUS placebo DPI (DEVICE), HandiHaler placebo DPI (DEVICE), Inhaler preference questionnaires (OTHER).

Who is sponsoring clinical trial NCT03227445?

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

Where is trial NCT03227445 being conducted?

This trial has 18 study locations across Florida, Louisiana, Missouri, North Carolina, Ohio. 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.