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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184624
• Other study ID #: 200301
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2014
• Last updated: November 19, 2015
• Start date: August 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.
• DISKUS/ACCUHALER
Placebo inhaler with one blister strip containing lactose monohydrate.
• MDI
Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane).
• TURBUHALER
Placebo inhaler containing lactose monohydrate.
• HANDIHALER
Placebo inhaler containing lactose monohydrate in a capsule.
• BREEZEHALER
Placebo inhaler containing lactose monohydrate in a capsule.

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Almere
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
United Kingdom	GSK Investigational Site	Portsmouth
United Kingdom	GSK Investigational Site	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 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.	Day 1	No
Secondary	The percentage of subjects making at least one critical error after the first instruction from the HCP	In each sub-study, if the subject makes any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP will demonstrate the correct use of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors will be recorded by the 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	No
Secondary	The percentage of subjects making at least one overall 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 HCP. The same procedures will be followed for the second inhaler. An overall error includes a critical and non-critical error.	Day 1	No
Secondary	The percentage of subjects making at least one overall error after the first instruction on use by the HCP	In each sub-study, if the subject makes any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP will demonstrate the correct usage of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors will be recorded by the HCP. The same procedures will be followed for the second inhaler. An overall error includes a critical and non-critical error.	Day 1	No
Secondary	The number of instructions (maximum three times) from the HCP which are needed to demonstrate adequate inhalation technique	In each sub-study, if the subject makes any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP will demonstrate the correct usage of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors will be recorded by the HCP. The same procedures will be repeated if the subject continues to make errors in the use of the inhaler. In total, the HCP will demonstrate the use of the inhaler up to three times. Same procedures will be followed for second inhaler.	Day 1	No
Secondary	The percentage of subjects who found the ELLIPTA device 'easy to use' compared with the other devices as assessed by the 'ease of use' questionnaire	After completing the demonstration procedures of the inhalers, the HCP will ask the subject a number of questions from ease of use questionnaire. Ease of use questionnaire will consist of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question will have one response to chose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult).	Day 1	No
Secondary	The percentage of subjects who prefer the ELLIPTA device compared to the other devices as assessed by the 'preference' questionnaire.	After completing the demonstration procedures of the inhalers, the HCP will ask the subject a number of questions from preference questionnaire after completing the ease of use questionnaire.	Day 1	No