To Study Device Attributes by Investigating Errors Made in Use, Ease of Use and Preference Among Different Inhalers in Subjects With Asthma

NCT02195284 | Completed Phase 4

• 1 other identifier: 200330
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 4

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.

Conditions

Asthma

Keywords

Inhaler preference; Overall inhaler error; DISKUS/ACCUHALER; MDI; TURBUHALER; ELLIPTA; Ease of use; Critical inhaler error

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects making at least one critical error after reading the patient information leaflet

  In each sub-study, subjects will be asked to read the patient instruction leaflet of the first device and then asked to demonstrate inhaler use. Any errors (critical or non-critical) made by the subject while using the first inhaler will be recorded by the health care professional (HCP). The same procedures will be followed for the second inhaler. A critical error is defined as an error that is most likely to result in no or only minimal medication being inhaled

  Day 1

Secondary Outcomes (6)

• Percentage of subjects making at least one critical error after the first instruction from HCP

  Day 1

• Percentage of subjects making at least one overall error after reading the patient information leaflet

  Day 1

• The percentage of subjects making at least one overall error after the first instruction on use by the HCP

  Day 1

• The number of instructions (maximum three times) from the HCP which are needed to demonstrate adequate inhalation technique

  Day 1

• The percentage of subjects who prefer the ELLIPTA device compared to the other devices as assessed by the 'preference' questionnaire

  Day 1

Study Arms (3)

Sub-study 1

EXPERIMENTAL

Subjects will be randomized to either use ELLIPTA inhaler first and then DISKUS/ACCUHALER inhaler or use DISKUS/ACCUHALER inhaler first and then ELLIPTA inhaler

Device: ELLIPTA; Device: DISKUS/ACCUHALER

Sub-study 2

EXPERIMENTAL

Subjects will be randomized to either use ELLIPTA inhaler first and then MDI (metered-dose inhaler) or use MDI first and then ELLIPTA inahler

Device: ELLIPTA; Device: MDI

Sub-study 3

EXPERIMENTAL

Subjects will be randomized to either use ELLIPTA inhaler first and then TURBUHALER inhaler or use TURBUHALER inhaler first and then ELLIPTA inhaler

Device: ELLIPTA; Device: TURBUHALER

Interventions

ELLIPTA DEVICE

Dry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate

Sub-study 1; Sub-study 2; Sub-study 3

DISKUS/ACCUHALER DEVICE

Placebo inhaler with one blister strip containing lactose monohydrate.

Sub-study 1

MDI DEVICE

Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane)

Sub-study 2

TURBUHALER DEVICE

Placebo inhaler containing lactose monohydrate.

Sub-study 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Enschede, 7513 ER, Netherlands

Location

GSK Investigational Site

Zutphen, 7207 AE, Netherlands

Location

GSK Investigational Site

Portsmouth, PO6 3LY, United Kingdom

Location

GSK Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27883002 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 23, 2015

Record last verified: 2015-09

Locations

NL (2); GB (2)