Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects
Public ClinicalTrials.gov record NCT02586493. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Study of the Correct Use and Ease of Use of Placebo ELLIPTA Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02586493
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 278 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2015
- Primary completion
- Feb 29, 2016
- Completion
- Mar 14, 2016
- Last update posted
- Nov 8, 2017
2015 – 2016
United States locations
- U.S. sites
- 16
- U.S. states
- 6
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Jasper | Alabama | 35501 | — |
| GSK Investigational Site | Clearwater | Florida | 33765 | — |
| GSK Investigational Site | Orlando | Florida | 32825 | — |
| GSK Investigational Site | Ormond Beach | Florida | 32174 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | — |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | — |
| GSK Investigational Site | Charleston | South Carolina | 29406-7108 | — |
| GSK Investigational Site | Easley | South Carolina | 29640 | — |
| GSK Investigational Site | Greenville | South Carolina | 29615 | — |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | — |
| GSK Investigational Site | Rock Hill | South Carolina | 29732 | — |
| GSK Investigational Site | Seneca | South Carolina | 29678 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Union | South Carolina | 29379 | — |
| GSK Investigational Site | Richmond | Virginia | 23225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02586493, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 8, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02586493 live on ClinicalTrials.gov.