ELLIPTA™ vs. MDI Inhaler Preference Study, in Adult Subjects With Asthma
Public ClinicalTrials.gov record NCT02135718. 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
A Preference Study of Inhaler Attributes Between Two Inhalers; ELLIPTA and MDI, in Adult Subjects With Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, stratified, and randomized, open-label, placebo study in subjects with asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose inhalers (MDI). This study is conducted to evaluate subject's preference of several inhaler-specific attributes individually between an existing MDI and the ELLIPTA a dry powder inhaler. Subjects who have not used the ELLIPTA inhaler in the past 6 months and their asthma must be controlled on their current therapy were enrolled. Subjects meeting the eligibility criteria will be stratified according to their current inhaler use (stable for the past 3 months): 1.) Currently using a DPI as an inhaled asthma controller therapy OR 2.) Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in the last 3 months) OR 3.) Currently using no inhaled asthma controller therapy (this includes patients using a LTM and/or SABA only). Once stratified, eligible subjects were randomized (1:1) to one of two sequences for using the inhaler: ELLIPTA inhaler once daily in Period 1 followed by MDI twice daily in Period 2 or MDI twice daily in Period 1 followed by ELLIPTA inhaler once daily in Period 2 for for 5-9 days each. In addition, subjects will be randomly assigned (1:1 allocation) to receive one of two sets of questions: Version 1 presents response options in the order of ELLIPTA inhaler, MDI, No preference; Version 2 presents response options in the order of MDI, ELLIPTA inhaler, No preference. At the end of the second trial period, subjects answered questions which assessed their preference of inhaler attributes. ELLIPTA is a registered trademark of the GSK group of companies.
Study identification
- NCT ID
- NCT02135718
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 288 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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
- May 31, 2014
- Primary completion
- Jun 30, 2014
- Completion
- Jun 30, 2014
- Last update posted
- Jun 7, 2016
2014
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Huntington Beach | California | 92647 | — |
| GSK Investigational Site | Newport Beach | California | 92663 | — |
| GSK Investigational Site | Vista | California | 92083 | — |
| GSK Investigational Site | Aventura | Florida | 33180 | — |
| GSK Investigational Site | Baltimore | Maryland | 21236 | — |
| GSK Investigational Site | Bethesda | Maryland | 20814 | — |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | — |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | — |
| GSK Investigational Site | Canton | Ohio | 44718 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Austin | Texas | 78750 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
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 NCT02135718, 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 Jun 7, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02135718 live on ClinicalTrials.gov.