Clinical trial NCT02184624: Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices
Official title: An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices (ELLIPTA, TURBUHALER, HANDIHALER, BREEZHALER, MDI, and DISKUS/ACCUHALER) in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: BREEZHALER
DISKUS/ACCUHALER
MDI
Inhaler preference
Overall inhaler error
HANDIHALER
Ease of use
TURBUHALER
ELLIPTA
Critical inhaler error
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 569
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomised, open-label, placebo, crossover, multicentre study with a single visit. The study will comprise five 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 randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other inhaler devices that will be used in this study will be included. Furthermore, subjects who are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler devices that requires a capsule. The study will be conducted in the UK and the Netherlands, and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be allocated to one of the sub-studies depending on their experience of using the other inhaler (i.e., depending on which other inhaler they are naïve to).

This study is designed to assess the proportion of COPD subjects making critical and overall (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference between the ELLIPTA inhaler and the other commercially available inhaler devices.

ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH \& Co. KG. BREEZHALER is a registered trademark of Novartis AG.


Eligibility criteria: Inclusion Criteria:

* Informed consent: Subject must give their signed and dated written informed consent to participate in the study; 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: \>=40 years of age
* Gender: Male or female subjects.
* Primary diagnosis of COPD: subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society. Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
* COPD treatment: All patients should be currently receiving treatment for COPD.
* Must be naïve to using ELLIPTA inhaler and at least one other inhaler device. Subjects who are naïve to the BREEZEHALER and HANDIHALER inhalers must be naïve to all other inhaler devices that requires a capsule.

Exclusion Criteria:

* Asthma: Subjects with a current diagnosis of asthma only. Note: Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
* 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 Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet
timeFrame: Day 1
measure: Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP
timeFrame: Day 1
measure: Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP
timeFrame: Day 1
measure: Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique
timeFrame: Day 1
measure: Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire
timeFrame: Day 1
measure: Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: GSK Investigational Site
city: Beek
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Kloosterhaar
country: Netherlands
facility: GSK Investigational Site
city: Nijverdal
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.