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NCT02135718 · ClinicalTrials.gov registry record
ELLIPTA™ vs. MDI Inhaler Preference Study, in Adult Subjects With Asthma
A clinical trial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 288
- Enrollment target
NCT02135718: Completed study, sponsored by GlaxoSmithKline.
NCT02135718 is a clinical trial that has completed, run by GlaxoSmithKline. The registered enrollment target is 288 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02135718 has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 288 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on the number of steps needed to use the inhaler was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall.
Interventions
- DEVICE ELLIPTA inhaler
- DEVICE Placebo Inhalation Aerosol (MDI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2014-06 |
| Est. Completion | 2014-07 |
What the finished NCT02135718 record still lists
NCT02135718 is an observational study that tracks outcomes without assigning an intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which ELLIPTA inhaler is the first listed.
NCT02135718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02135718 about?
NCT02135718 is a clinical study titled "ELLIPTA™ vs. MDI Inhaler Preference Study, in Adult Subjects With Asthma". 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 individual...
What is the current status of trial NCT02135718?
This trial is currently completed. The enrollment target is 288 participants. The study started on 2014-06. Estimated completion is 2014-07.
What interventions are being tested in trial NCT02135718?
The interventions under investigation include: ELLIPTA inhaler (DEVICE), Placebo Inhalation Aerosol (MDI) (DEVICE).
Who is sponsoring clinical trial NCT02135718?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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