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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: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT02786927 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 214 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Preference between ELLIPTA inhaler and Handihaler based on the number of steps needed to take the medication was assessed by the inhaler preference questionnaire at Visit 3 or Early Withdrawal (EW) visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version. The analysis was performed on the Modified Intent-to-treat (ITT) Population comprised of all participants in the ITT Population (comprised all randomiz
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
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2016-06-21 |
| Est. Completion | 2016-10-04 |
| Phase | Phase 4 |
What the finished NCT02786927 record still lists
NCT02786927 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo ELLIPTA device is the first listed.
NCT02786927 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02786927's enrollment target sits among peer trials
214 394th of 2000 higher than 1,605 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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