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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

NCT ID: NCT04813354

Last Updated: 2023-05-15

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2021-07-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study will be a randomized, multi-center, open label, placebo- controlled device handling study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ELLIPTA/ BREEZHALER/Questionnaire version 1

Participants received placebo ELLIPTA Dry Powder Inhaler (DPI) followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and visual analogue scale (VAS) on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.

Group Type EXPERIMENTAL

ELLIPTA

Intervention Type DEVICE

* 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

BREEZHALER

Intervention Type DEVICE

* 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

ELLIPTA/ BREEZHALER/Questionnaire version 2

Participants received placebo ELLIPTA DPI followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.

Group Type EXPERIMENTAL

ELLIPTA

Intervention Type DEVICE

* 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

BREEZHALER

Intervention Type DEVICE

* 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

BREEZHALER/ ELLIPTA/Questionnaire version 1

Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.

Group Type EXPERIMENTAL

ELLIPTA

Intervention Type DEVICE

* 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

BREEZHALER

Intervention Type DEVICE

* 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

BREEZHALER/ ELLIPTA/Questionnaire version 2

Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.

Group Type EXPERIMENTAL

ELLIPTA

Intervention Type DEVICE

* 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

BREEZHALER

Intervention Type DEVICE

* 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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants must be aged 18 years or older at the time of signing the informed consent.
* Participants who have a confirmed mild or moderate asthma diagnosis as per Global Initiative for Asthma (GINA), 2020.
* Participants must be on asthma maintenance therapy (Inhaled corticosteroids \[ICS\] or ICS/ Long acting beta 2-agonist \[LABA\]) for at least 12 weeks prior to study participation.
* Participants must be naïve to both the ELLIPTA and BREEZHALER inhalers.
* Females who are not pregnant or not planning a pregnancy during the study or not Lactating.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

* Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders.
* History of hypersensitivity to any components of the study inhaler (e.g., lactose). In addition, participants with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
* Historical or current evidence of clinically significant or rapidly progressing or unstable disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study.
* Drug/alcohol abuse: Participants with a known or suspected alcohol or drug abuse, which in the opinion of the investigator could interfere with the participant's proper completion of the protocol requirement.
* A participant will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator, as well as employees of GSK or Novartis.
* Inability to Read: In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions.
* Medical and physical conditions that in the opinion of the investigator could impact the ability of the participant to manipulate the inhaler.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Enschede, , Netherlands

Site Status

GSK Investigational Site

Nijverdal, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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van der Palen J, Slade D, Rehal S, Verma M, Plank M. A randomized, cross-over study comparing critical and overall errors, learning time, and preference of the ELLIPTA versus BREEZHALER dry powder inhalers in patients with asthma. Respir Med. 2022 Dec;205:107031. doi: 10.1016/j.rmed.2022.107031. Epub 2022 Oct 28.

Reference Type DERIVED
PMID: 36368290 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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213306

Identifier Type: -

Identifier Source: org_study_id

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