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NCT02586493 · ClinicalTrials.gov registry record · Phase 4
Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects
A Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 278
- Enrollment target
- 16
- Study locations
NCT02586493 is a Phase 4 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 278 participants, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (73% lower). The trial reports 16 study locations across 6 states.
The verdict
NCT02586493, a Phase 4 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 278 participants
- Enrollment target
- 16
- Study locations
Study Summary
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The mainstay for treatment involves the use of inhaled medications, including short and/or long-acting bronchodilators along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study will assess the correct use of the ELLIPTA inhaler by subjects with COPD and to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of COPD and receiving COPD therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2. ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
Conditions Studied
Interventions
- DRUG Placebo
- OTHER Questionnaire
Study Locations (16)
South Carolina
- GSK Investigational Site - Charleston
- GSK Investigational Site - Easley
- GSK Investigational Site - Greenville
- GSK Investigational Site - Mt. Pleasant
- GSK Investigational Site - Rock Hill
- GSK Investigational Site - Seneca
- GSK Investigational Site - Spartanburg
- GSK Investigational Site - Union
Florida
- GSK Investigational Site - Clearwater
- GSK Investigational Site - Orlando
- GSK Investigational Site - Ormond Beach
Minnesota
- GSK Investigational Site - Minneapolis
- GSK Investigational Site - Plymouth
Alabama
- GSK Investigational Site - Jasper
Ohio
- GSK Investigational Site - Cincinnati
Virginia
- GSK Investigational Site - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2015-10-01 |
| Est. Completion | 2016-03-15 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02586493
The ClinicalTrials.gov registry entry for NCT02586493 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 278 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (73% 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 2 interventions - of which Placebo is the first listed.
NCT02586493 reports 16 study locations spanning 6 distinct geographic areas - top geographies include South Carolina, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02586493 about?
NCT02586493 is a clinical study titled "Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects". Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The mainstay for treatment involves the use of inhaled medications, including short and/or long-acting bronchodilators along with inhaled corticostero...
What is the current status of trial NCT02586493?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 278 participants. The study started on 2015-10-01. Estimated completion is 2016-03-15.
What conditions does trial NCT02586493 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT02586493?
The interventions under investigation include: Placebo (DRUG), Questionnaire (OTHER).
Who is sponsoring clinical trial NCT02586493?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02586493 being conducted?
This trial has 16 study locations across Alabama, Florida, Minnesota, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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