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NCT03478657 · ClinicalTrials.gov registry record · Phase 4
An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA DPI in Pediatric Subjects With Asthma
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 222
- Enrollment target
NCT03478657 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 222 participants.
The verdict
NCT03478657, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 222 participants
- Enrollment target
Study Summary
Asthma is a chronic inflammatory disease of airways and lungs that results in hyper-reactivity and clinically relevant episodes of wheezing. This study has been designed to assess the correct use and ease of use of the ELLIPTA® DPI in pediatric subjects with asthma. ELLIPTA DPI is easy to use, requires few steps, is consistent in dosing and eliminates the hand-breath co-ordination required for metered dose inhalers (MDIs). Subjects will be stratified by age into two strata: Stratum 1: subjects in the age group of 5 to 7 years and Stratum 2: Subjects in the age group of 8 to 11 years. All subjects will be trained by Health care professionals (HCP) for the correct use of ELLIPTA DPI. Subjects will be given three chances to attempt correct use of ELLIPTA DPI; subsequently, if the subject is not successful, the parent/guardian will be able to help instruct the subject on the correct use of the ELLIPTA DPI, for two more attempts. The subjects who will be enrolled in the study will take placebo ELLIPTA DPI once daily. After 28 days subjects will be randomized in 1:1 to receive a questionnaire (Version A and B). After completion of the questionnaire on ELLIPTA DPI ease of use, subject's ability to use ELLIPTA DPI correctly will be re-assessed. Approximately 219 subjects will be screened to participate in the study. The study will be conducted for 28 days. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Interventions
- DRUG Placebo DPI
- DEVICE ELLIPTA DPI
- OTHER Ease of use questionnaires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2018-12-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03478657
The ClinicalTrials.gov registry entry for NCT03478657 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo DPI is the first listed.
NCT03478657 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03478657 about?
NCT03478657 is a clinical study titled "An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA DPI in Pediatric Subjects With Asthma". Asthma is a chronic inflammatory disease of airways and lungs that results in hyper-reactivity and clinically relevant episodes of wheezing. This study has been designed to assess the correct use and ease of use of the ELLIPTA® DPI in pediatric subjects with asthma. ELLIPTA DPI is easy to use, requi...
What is the current status of trial NCT03478657?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 222 participants. The study started on 2018-06-18. Estimated completion is 2018-12-07.
What interventions are being tested in trial NCT03478657?
The interventions under investigation include: Placebo DPI (DRUG), ELLIPTA DPI (DEVICE), Ease of use questionnaires (OTHER).
Who is sponsoring clinical trial NCT03478657?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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