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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: Completed Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A checklist for correct use of each inhaler was developed in Patient Instruction Leaflets (PIL's). Participants were guided by trained health care provider (HCP) to demonstrate correct use of inhaler. Baseline assessment was conducted when participant initially dispensed the inhaler. Second assessment was conducted after each 28day dosing period. Correct Use Check list was completed by HCP at each visit. Primary hypothetical estimand is the estimate of treatment effect of all participants who st
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2018-01-04 |
| Phase | Phase 4 |
What the finished NCT03227445 record still lists
NCT03227445 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (77% lower).
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 lists 18 locations in 9 states (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.
Learn More About Clinical Trials
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Where NCT03227445's enrollment target sits among peer trials
240 44th of 74 higher than 31 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.
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