Last updated: 11/08/2018 17:21:25
Study of inhaler device attributes investigating critical and overall errors, ease of use, and preference between a number of inhaler devices
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Percentage of participants who made at least one critical error after reading the patient information leaflet
Timeframe: Day 1
Secondary outcomes:
Percentage of participants who made at least one overall error after reading the patient information leaflet
Timeframe: Day 1
Percentage of participants making at least one critical error after the first instruction from the HCP
Timeframe: Day 1
Percentage of participants making at least one overall error after the first instruction from the HCP
Timeframe: Day 1
Number of participants needed instructions from HCP (maximum three times) to demonstrate adequate inhalation technique
Timeframe: Day 1
Percentage of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers as assessed by the preference questionnaire
Timeframe: Day 1
Percentage of participants who overall found the ELLIPTA device easy to use compared with non-ELLIPTA inhalers as assessed by the ease of use questionnaire
Timeframe: Day 1
Interventions:
Device: ELLIPTA
Device: DISKUS/ACCUHALER
Device: MDI
Device: TURBUHALER
Device: HANDIHALER
Device: BREEZEHALER
Enrollment:
569
Observational study model:
Not applicable
Primary completion date:
2015-31-07
Time perspective:
Not applicable
Clinical publications:
J van der Palen, M Thomas, H Chrystyn, RK Sharma, PDLPM van der Valk, M Goosens, Tom Wilkinson, Carol Stonham, Anoop G. Chauhan, V Imber, C-Q Zhu, H Svedsater, NC Barnes.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 J.2017;27:17001
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
August 2014 to July 2015
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- 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
- 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.
Inclusion and exclusion criteria
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 location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-31-07
Actual study completion date
2015-31-07
Plain language summaries
Summary of results in plain language
Available language(s): Dutch, English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
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