Clinical trial NCT02195284: To Study Device Attributes by Investigating Errors Made in Use, Ease of Use and Preference Among Different Inhalers in Subjects With Asthma
Official title: An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, and Ease of Use and Preference Between a Number of Inhaler Devices (ELLIPTA, DISKUS/ACCUHALER, TURBUHALER, and MDI) in Adult Subjects With Asthma (Study 200330)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Inhaler preference
Overall inhaler error
DISKUS/ACCUHALER
MDI
TURBUHALER
ELLIPTA
Ease of use
Critical inhaler error
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is designed to assess the proportion of asthma subjects making critical and non-critical errors made in using ELLIPTA® inhaler compared with other commercially available inhaler devices such as the TURBUHALER®, MDI (metered-dose inhaler), and DISKUS/ACCUHALER®. This study will also assess the ease of use and preference between the ELLIPTA inhaler and the other commercially available inhaler devices. This is a randomized, open-label, placebo, crossover, multicentre study with a single visit. The study will comprise three sub-studies. Subjects will receive inactive treatment (placebo) via the ELLIPTA inhaler and one of the other inhaler devices depending on the sub-study they are allocated to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other inhalers that will be used in this study will be included. The study will be conducted in the Netherlands and the UK, and comprises one visit only. A sufficient number of subjects (at least 190) with asthma will be screened and 180 will be randomized to one of the three sub-studies. Eligible subjects will be allocated to one of the sub-studies in the following order depending on their experience of using the other inhaler (i.e., depending on which other inhaler they are naïve to).

ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca.

Detailed description: This is a non-interventional study and not an observational study and therefore some fields are not applicable for the CT.gov observational study design. It would be preferential to have the field populated as "not applicable" for sampling method, time perspective, and observational study model as they don't apply to this study design.

Eligibility criteria: Inclusion Criteria:

* Informed consent: Subject must give their signed and dated written informed consent to participate; Subject understands and is willing, able, and likely to comply with study procedures and restrictions; Subject must be able to read, comprehend, and record information in Dutch and/or English
* Age: \>=18 years of age
* Gender: Male or female subjects.
* Asthma Diagnosis: A diagnosis of asthma as defined by the National Institutes of Health. Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
* Asthma treatment: All subjects should be currently receiving treatment for asthma.
* Must be naive to using ELLIPTA inhaler and at least one other inhaler device.

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of COPD only.
* Contraindications: A history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
* Subjects who are currently participating in another randomised pharmacological interventional trial.
* Inability to Read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions

Primary outcomes:
measure: Percentage of subjects making at least one critical error after reading the patient information leaflet
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of subjects making at least one critical error after the first instruction from HCP
timeFrame: Day 1
measure: Percentage of subjects making at least one overall error after reading the patient information leaflet
timeFrame: Day 1
measure: The percentage of subjects making at least one overall error after the first instruction on use by the HCP
timeFrame: Day 1
measure: The number of instructions (maximum three times) from the HCP which are needed to demonstrate adequate inhalation technique
timeFrame: Day 1
measure: The percentage of subjects who prefer the ELLIPTA device compared to the other devices as assessed by the 'preference' questionnaire
timeFrame: Day 1
measure: The percentage of subjects who found the ELLIPTA device 'easy to use' compared with the other devices' as assessed by the 'ease of use' questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Zutphen
country: Netherlands
facility: GSK Investigational Site
city: Portsmouth
country: United Kingdom
facility: GSK Investigational Site
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: van der Palen J, Thomas M, Chrystyn H, Sharma RK, van der Valk PD, Goosens M, Wilkinson T, Stonham C, Chauhan AJ, Imber V, Zhu CQ, Svedsater H, Barnes NC. A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices. NPJ Prim Care Respir Med. 2016 Nov 24;26:16079. doi: 10.1038/npjpcrm.2016.79.