Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: ELLIPTA
BREEZHALER
Dry powder inhaler
Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be a randomized, multi-center, open label, placebo- controlled device handling study.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP
timeFrame: Day 1
measure: Percentage of Participants Making at Least One Overall Error After Reading PIL
timeFrame: Day 1
measure: Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP
timeFrame: Day 1
measure: Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
timeFrame: Day 1
measure: Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use
timeFrame: Day 1
measure: Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1)
timeFrame: Day 1
measure: Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2)
timeFrame: Day 1
measure: Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2)
timeFrame: Day 1
measure: Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
timeFrame: Day 1
measure: Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
timeFrame: Day 1
measure: Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler
timeFrame: Day 1
measure: Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Nijverdal
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.