DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)
Public ClinicalTrials.gov record NCT01868009. 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
RLV116669, A Preference Study of Device Attributes Between Two Placebo Dry Powder Inhalers; ELLIPTA and DISKUS, in Adult Subjects With Chronic Obstructive Pulmonary Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months will be screened to participate in the study. Subjects will have an equal chance of being in any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the DISKUS inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The other group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period (twice daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5 to9 days). At the end of the second period, subjects will complete the study by answering 7 questions to assess their preference of device attributes and dosing regimens between the two inhalers. The null hypothesis for device preference for a specific attribute is that 50% subjects express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA is unity. The null hypothesis for dosing regimen preference is that 50% subjects express a preference of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice daily dosing or have no preference).
Study identification
- NCT ID
- NCT01868009
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 287 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
- Apr 30, 2013
- Primary completion
- Jun 30, 2013
- Completion
- Jun 30, 2013
- Last update posted
- Mar 3, 2014
2013
United States locations
- U.S. sites
- 17
- U.S. states
- 10
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Jasper | Alabama | 35501 | — |
| GSK Investigational Site | Riverside | California | 92506 | — |
| GSK Investigational Site | Clearwater | Florida | 33765-2616 | — |
| GSK Investigational Site | Leesburg | Florida | 34748 | — |
| GSK Investigational Site | Orlando | Florida | 32825 | — |
| GSK Investigational Site | Lafayette | Louisiana | 70503 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Huntersville | North Carolina | 28078 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| 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 | Seneca | South Carolina | 29678 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Richmond | Virginia | 23225 | — |
| GSK Investigational Site | Spokane | Washington | 99204 | — |
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 NCT01868009, 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 Mar 3, 2014 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01868009 live on ClinicalTrials.gov.