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NCT03315572 · ClinicalTrials.gov registry record
Pediatric Ease of Use ELLIPTA Items
A clinical trial of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 28
- Enrollment target
- 2
- Study locations
NCT03315572: Completed study of Asthma, sponsored by GlaxoSmithKline.
NCT03315572 is a study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 28 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03315572, a study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
- 2
- Study locations
Study Summary
A range of devices has been developed to administer inhaled therapy for asthma, including dry powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat asthmatic subjects. The objective of this study is to revise ease of use items developed for adults to be appropriate for completion by pediatric subjects in future clinical trials and to evaluate the newly developed items in subjects with asthma aged 5 to 11 years and their caregivers. This is a cross-sectional, qualitative study that will involve pediatric subjects with asthma who are currently using an asthma maintenance inhaler and their caregivers. Two rounds of repetitive cognitive interviews will be conducted with 16 subjects in each interview set. Each interview will last approximately 45 minutes. Data provided by pediatric subjects and their caregivers during interview will be collected as field notes and audio recordings which will be transcribed.
Primary Outcome
The items for pediatric participants were developed to assess the concepts of overall ease of use of ELLIPTA and ease of evaluating remaining doses in inhaler. Pediatric participants aged 5 to 7 years were required to complete the interviewer-administered version and participants aged 8 to 11 years were administered self-completed version. Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses
Conditions Studied
Interventions
- OTHER Interviewer administered version of ease of use items
- OTHER Self-administered version of ease of use items
- OTHER Caregiver version of ease of use items
Study Locations (2)
Michigan
- GSK Investigational Site - Southfield
North Carolina
- GSK Investigational Site - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-10-17 |
| Est. Completion | 2017-12-01 |
What the finished NCT03315572 record still lists
NCT03315572 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Interviewer administered version of ease of use items is the first listed.
NCT03315572 reports a single indexed study location in Michigan, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03315572 about?
NCT03315572 is a clinical study titled "Pediatric Ease of Use ELLIPTA Items". A range of devices has been developed to administer inhaled therapy for asthma, including dry powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat asthmatic subjects. The objective of this study is to revise ease of use items developed for adults to be approp...
What is the current status of trial NCT03315572?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2017-10-17. Estimated completion is 2017-12-01.
What conditions does trial NCT03315572 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT03315572?
The interventions under investigation include: Interviewer administered version of ease of use items (OTHER), Self-administered version of ease of use items (OTHER), Caregiver version of ease of use items (OTHER).
Who is sponsoring clinical trial NCT03315572?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03315572 being conducted?
This trial has 2 study locations across Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03315572's enrollment target sits among peer trials
28 311th of 374 higher than 60 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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