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NCT02794480 · ClinicalTrials.gov registry record · Phase 4
Phase IV Study in Asthma Subjects for Dry Powder Inhaler (DPI) Versus (vs) Metered Dose Inhaler (MDI) Correct Use
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 324
- Enrollment target
NCT02794480 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 324 participants.
The verdict
NCT02794480, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 324 participants
- Enrollment target
Study Summary
The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label, cross-over study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess correct inhaler use. No active drug will be used in this study in order to prevent any drug-related effects. Approximately, 152 subjects will be randomized to receive ELLIPTA DPI inhaler and 152 will be randomized to receive one of the MDI inhalers, for use during the first period (P) (approximately 28 days). At Visit 2 (Day 28) all subjects previous receiving the ELLIPTA DPI will be randomized to receive one of the MDI inhalers and all subjects who received a MDI in the previous period will receive the ELLIPTA DPI for use during second period (approximately 28 days). Subjects will continue taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period. ELLIPTA is a registered trademark of the GSK group of companies.
Interventions
- DEVICE ELLIPTA DPI
- DEVICE GSK MDI
- DEVICE AZ MDI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2016-08-22 |
| Est. Completion | 2016-12-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02794480
The ClinicalTrials.gov registry entry for NCT02794480 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 324 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 ELLIPTA DPI is the first listed.
NCT02794480 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02794480 about?
NCT02794480 is a clinical study titled "Phase IV Study in Asthma Subjects for Dry Powder Inhaler (DPI) Versus (vs) Metered Dose Inhaler (MDI) Correct Use". The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK MDI and the AstraZeneca...
What is the current status of trial NCT02794480?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 324 participants. The study started on 2016-08-22. Estimated completion is 2016-12-15.
What interventions are being tested in trial NCT02794480?
The interventions under investigation include: ELLIPTA DPI (DEVICE), GSK MDI (DEVICE), AZ MDI (DEVICE).
Who is sponsoring clinical trial NCT02794480?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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