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NCT02786927 · ClinicalTrials.gov registry record · Phase 4

Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
214
Enrollment target

NCT02786927 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 214 participants.

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The verdict

NCT02786927, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
214 participants
Enrollment target

Study Summary

This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER DPI. The primary objective of this study is to evaluate whether more subjects with COPD prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take medication. All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding treatment periods based on the randomisation scheme, and at the end of 2 periods, complete the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily for 5-9 days in each treatment period. This study will be placebo-only, and neither inhaler will contain active treatment. Subjects will continue their current COPD medication(s) as prescribed, and will follow up with their regular physician for their COPD healthcare during the study. Approximately 211 subjects will be enrolled in the study. ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark of Boehringer Ingelheim International GmbH.

Interventions

  • DRUG Placebo ELLIPTA device
  • DRUG Placebo capsules for use in HANDIHALER device
  • OTHER Inhaler Preference Questionnaire Version 1
  • OTHER Inhaler Preference Questionnaire Version 2

Trial Details

FieldValue
Enrollment Target 214 participants
Start Date 2016-06-21
Est. Completion 2016-10-04
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT02786927

The ClinicalTrials.gov registry entry for NCT02786927 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 214 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 4 interventions - of which Placebo ELLIPTA device is the first listed.

NCT02786927 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02786927 about?

NCT02786927 is a clinical study titled "Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER DPI. The primary objective of this ...

What is the current status of trial NCT02786927?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 214 participants. The study started on 2016-06-21. Estimated completion is 2016-10-04.

What interventions are being tested in trial NCT02786927?

The interventions under investigation include: Placebo ELLIPTA device (DRUG), Placebo capsules for use in HANDIHALER device (DRUG), Inhaler Preference Questionnaire Version 1 (OTHER), Inhaler Preference Questionnaire Version 2 (OTHER).

Who is sponsoring clinical trial NCT02786927?

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.