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Comparative Study of ELLIPTA Dry Powder Inhaler (DPI) Versus DISKUS DPI Used With HandiHaler DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT03227445 · View on ClinicalTrials.gov ↗
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
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 |
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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03227445 reports 18 study locations spanning 9 distinct geographic areas — top geographies include North Carolina, South Carolina, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03227445?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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