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Completed

NCT Number: NCT02195284

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Enschede, Netherlands

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About this study

This is a non-interventional study and not an observational study and therefore some fields are not applicable for the CT.gov observational study design. It would be preferential to have the field populated as "not applicable" for sampling method, time perspective, and observational study model as they don't apply to this study design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

DISKUS/ACCUHALER

Device

Placebo inhaler with one blister strip containing lactose monohydrate.

MDI

Device

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

TURBUHALER

Device

Placebo inhaler containing lactose monohydrate.

Primary outcomes

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

    Time frame: Day 1

    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

Secondary outcomes

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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 (critical or non-critical) 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

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

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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. Preference questionnaire will consist of eight questions with each question having one response to chose from 3 options of preference (Other inhaler device, ELLIPTA inhaler device, No preference)

  6. 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

    Time frame: Day 1

    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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, and Ease of Use and Preference Between a Number of Inhaler Devices (ELLIPTA, DISKUS/ACCUHALER, TURBUHALER, and MDI) in Adult Subjects With Asthma (Study 200330)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2014
Registry last updated
Nov 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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