Last updated: 11/07/2018 11:45:16
To study device attributes by investigating errors made in use, ease of use and preference among different inhalers in subjects with asthma
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, 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)
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Percentage of participants making at least one critical error after reading the participant information leaflet (PIL)
Timeframe: Day 1
Secondary outcomes:
Percentage of participants making at least one critical error after the first instruction from health care professional (HCP)
Timeframe: Day 1
Percentage of participants making at least one overall error after reading the PIL
Timeframe: Day 1
Percentage of participants making at least one overall error after the first instruction on use by the HCP
Timeframe: Day 1
Percentage of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique
Timeframe: Day 1
Percentage of participants preferring ELLIPTA device compared to the other devices as assessed by the ‘preference’ questionnaire
Timeframe: Day 1
Percentage of participants preferring ELLIPTA device compared to other devices as assessed by the ‘ease of use’ questionnaire
Timeframe: Day 1
Interventions:
Device: ELLIPTA
Device: DISKUS/ACCUHALER
Device: MDI
Device: TURBUHALER
Enrollment:
162
Observational study model:
Not applicable
Primary completion date:
2015-19-05
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
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
November 2014 to May 2015
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- 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.
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
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
2015-19-05
Actual study completion date
2015-19-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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