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

NCT02184624 | Completed Phase 4 Results

• 1 other identifier: 200301
• Study Type: interventional
• Target: 569
• Locations: 2 countries
• Sites: 8

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet

  A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.

  Day 1

Secondary Outcomes (6)

• Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet

  Day 1

• Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP

  Day 1

• Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP

  Day 1

• Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique

  Day 1

• Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire

  Day 1

Study Arms (5)

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 inhaler or use MDI inhaler first and then ELLIPTA inhaler.

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.

Device: ELLIPTA; Device: TURBUHALER

Sub-Study 4

EXPERIMENTAL

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

Device: ELLIPTA; Device: HANDIHALER

Sub-Study 5

EXPERIMENTAL

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

Device: ELLIPTA; Device: BREEZEHALER

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; Sub-Study 4; Sub-Study 5

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

HANDIHALER DEVICE

Placebo inhaler containing lactose monohydrate in a capsule.

Sub-Study 4

BREEZEHALER DEVICE

Placebo inhaler containing lactose monohydrate in a capsule.

Sub-Study 5

Eligibility Criteria

• Age: 40 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Almere Stad, 1311 RL, Netherlands

Location

GSK Investigational Site

Beek, 6191 JW, Netherlands

Location

GSK Investigational Site

Enschede, 7513 ER, Netherlands

Location

GSK Investigational Site

Kloosterhaar, 7694 AC, Netherlands

Location

GSK Investigational Site

Nijverdal, 7442 LS, 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

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: August 28, 2014
• Primary Completion: July 31, 2015
• Study Completion: July 31, 2015
• Last Updated: May 23, 2017
• Results First Posted: March 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (2); NL (6)