NCT04813354

A Comparison of Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Versus BREEZHALER Dry Powder Inhalers (DPIs) in Adult Participants With Asthma

A Randomized, Multi-center, Open-label, Cross-over Study Comparing Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Dry Powder Inhaler Versus the BREEZHALER Dry Powder Inhaler, in Adult Participants With Mild to Moderate Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to provide data in adult participants with mild to moderate asthma to assist healthcare professionals (HCPs) in assessing various attributes of ELLIPTA and BREEZHALER DPIs, by comparing the incidence of critical and overall errors, participant preference, willingness to continue with the inhaler and time to correct use. ELLIPTA® is a registered trademark of GlaxoSmithKline (GSK) and BREEZHALER® is a registered trademark of Novartis.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	ELLIPTA	* ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1 * ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2 * BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1 * BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2
DEVICE	BREEZHALER	* ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1 * ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2 * BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1 * BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2

Timeline

• Start date: 2021-04-14
• Primary completion: 2021-07-08
• Completion: 2021-07-08
• First posted: 2021-03-24
• Last updated: 2023-05-15
• Results posted: 2023-05-15

Locations

3 sites across 1 country: Netherlands