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

NCT ID: NCT02195284

Last Updated: 2015-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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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 (metered-dose inhaler) or use MDI first and then ELLIPTA inahler

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 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

TURBUHALER

Intervention Type DEVICE

Placebo inhaler containing lactose monohydrate.

Interventions

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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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Enschede, , Netherlands

Site Status

GSK Investigational Site

Zutphen, , Netherlands

Site Status

GSK Investigational Site

Portsmouth, , United Kingdom

Site Status

GSK Investigational Site

Southampton, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

References

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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)

Other Identifiers

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200330

Identifier Type: -

Identifier Source: org_study_id