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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: Completed Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution. The percentage is based off the number of participants analyzed i.e the number of sub
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 |
What the finished NCT02586493 record still lists
NCT02586493 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (73% lower).
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 lists 16 locations in 6 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02586493's enrollment target sits among peer trials
278 40th of 74 higher than 35 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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