Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices

NCT ID: NCT02184624

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 569 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-28
• Study Completion Date: 2015-07-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sub-Study 1

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.

Group Type: EXPERIMENTAL

ELLIPTA

Intervention Type: 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.

DISKUS/ACCUHALER

Intervention Type: DEVICE

Placebo inhaler with one blister strip containing lactose monohydrate.

Sub-Study 2

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

Group Type: EXPERIMENTAL

ELLIPTA

Intervention Type: 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.

MDI

Intervention Type: DEVICE

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

Sub-Study 3

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

Group Type: EXPERIMENTAL

ELLIPTA

Intervention Type: 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.

TURBUHALER

Intervention Type: DEVICE

Placebo inhaler containing lactose monohydrate.

Sub-Study 4

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

Group Type: EXPERIMENTAL

ELLIPTA

Intervention Type: 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.

HANDIHALER

Intervention Type: DEVICE

Placebo inhaler containing lactose monohydrate in a capsule.

Sub-Study 5

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

Group Type: EXPERIMENTAL

ELLIPTA

Intervention Type: 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.

BREEZEHALER

Intervention Type: DEVICE

Placebo inhaler containing lactose monohydrate in a capsule.

Interventions

ELLIPTA

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.

Intervention Type: DEVICE

DISKUS/ACCUHALER

Placebo inhaler with one blister strip containing lactose monohydrate.

Intervention Type: DEVICE

MDI

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

Intervention Type: DEVICE

TURBUHALER

Placebo inhaler containing lactose monohydrate.

Intervention Type: DEVICE

HANDIHALER

Placebo inhaler containing lactose monohydrate in a capsule.

Intervention Type: DEVICE

BREEZEHALER

Placebo inhaler containing lactose monohydrate in a capsule.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Almere Stad, , Netherlands

GSK Investigational Site

Beek, , Netherlands

GSK Investigational Site

Enschede, , Netherlands

GSK Investigational Site

Kloosterhaar, , Netherlands

GSK Investigational Site

Nijverdal, , Netherlands

GSK Investigational Site

Zutphen, , Netherlands

GSK Investigational Site

Portsmouth, , United Kingdom

GSK Investigational Site

Southampton, , United Kingdom

Countries

Netherlands; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 27883002 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

200301

Identifier Type: -

Identifier Source: org_study_id