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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: HANDIHALER; Device: MDI; Device: ELLIPTA; Device: BREEZEHALER; Device: TURBUHALER; Device: DISKUS/ACCUHALER

Study type: Interventional

Funder types: Industry

Identifiers

NCT02184624

200301

Details and patient eligibility

About

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.

Enrollment: 569 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

569 participants in 5 patient groups

Sub-Study 1

Experimental group

Description:

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.

Treatment:

Device: ELLIPTA

Device: DISKUS/ACCUHALER

Sub-Study 2

Experimental group

Description:

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

Treatment:

Device: ELLIPTA

Device: MDI

Sub-Study 3

Experimental group

Description:

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

Treatment:

Device: ELLIPTA

Device: TURBUHALER

Sub-Study 4

Experimental group

Description:

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

Treatment:

Device: ELLIPTA

Device: HANDIHALER

Sub-Study 5

Experimental group

Description:

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

Treatment:

Device: ELLIPTA

Device: BREEZEHALER