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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.

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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

FieldValue
Enrollment Target 324 participants
Start Date 2016-08-22
Est. Completion 2016-12-15
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.