Last updated: 11/07/2018 11:46:25
A randomized, open-labelled non-drug interventional, cross-over, dry powder inhaler device preference study to compare “ease of use” of ELLIPTA (TM) inhaler with BREEZHALER (TM) inhaler in inhalation-device naïve Japanese volunteers aged 40 years or older
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, open-labelled non-drug interventional, cross-over, dry powder inhaler device preference study to compare “ease of use” of ELLIPTA (TM) inhaler with BREEZHALER (TM) inhaler in inhalation-device naïve Japanese volunteers aged 40 years or older
Trial description: This will be a single-centre, randomized, open-label, 2-period crossover study using another inhaler as controls without any pharmacological intervention.This study is designed to demonstrate ELLIPTA inhaler is easy to use in Japanese adult subjects aged 40 years or older with no history of regular use of a dry powder inhaler . The study will enroll subjects aged 40–64 years and >= 65 years in a ratio of 1:2. The male and female ratio will be 1:1. Each subject will be randomized to one of the two sequences from Sequence 1 to Sequence 2. Subjects will use two different inhalers ELLIPTA inhaler and BREEZHALER inhaler one after another in order designated by the allocated sequence. All two inhalers will be assessed on the same day by the same rater.ELLIPTA inhaler and BREEZHALER inhaler used in this study are not going to contain the active drugs.Empty capsules are going to be prepared for handling of BREEZHALER inhaler. This study will assess the technique in the inhaler handling until just before inhalation as subjects are not going to inhale.ELLIPTA inhaler is a trademark of GlaxoSmithKline pharmaceuticals.BREEZHALER is a trademark of Novartis AG.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Odds ratio of preference on “ease of use” between the two devices
Timeframe: Visit 1
Secondary outcomes:
Attainment level of unpacking operation (% of subjects with each level)
Timeframe: Visit 1
Mean time from start of handling instruction to acquiring ability to use
Timeframe: Visit 1
Preference rate of Easy device to know how many doses are left (% of subjects with each answer)
Timeframe: Visit 1
Preference rate of handling time (% of subjects with each answer)
Timeframe: Visit 1
Handling errors (% of subjects with any errors/each error)
Timeframe: Visit 1
Preference rate of handling steps (% of subjects with each answer)
Timeframe: Visit 1
Preference rate of Comfort of mouth piece (% of subjects with each answer)
Timeframe: Visit 1
Preference rate of ease of use (% of subjects with each answer)
Timeframe: Visit 1
Interventions:
Not applicable
Enrollment:
150
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Komase Y, Akimoto A, Kobayashi A, Sharma R.Ease of use preference for the ELLIPTA(R) dry powder inhaler (DPI) over a commonly-used single-dose capsule DPI by inhalation device-naïve Japanese volunteers aged 40 years or older.Int J Chron Obstruct Pulmon Dis.2014;9:1365-1375
- Japanese male or female aged 40 years or older
- Capable of providing written consent
- Previously used any dry powder inhaler regularly
- Have any condition that, in the opinion of the investigator (or subinvestigator), may have a major impact on his/her ability to operate the inhaler (e.g., rheumatism, eye disorder, dementia, finger disorder/injury)
Inclusion and exclusion criteria
Inclusion criteria:
- Japanese male or female aged 40 years or older
- Capable of providing written consent
Exclusion criteria:
- Previously used any dry powder inhaler regularly
- Have any condition that, in the opinion of the investigator (or subinvestigator), may have a major impact on his/her ability to operate the inhaler (e.g., rheumatism, eye disorder, dementia, finger disorder/injury)
- Have experience on using BREEZHALER inhaler, tiotropium via dry powder inhaler and/or ELLIPTA inhaler
- Judged by the investigator (or subinvestigator) to be inappropriate to participate in this study
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-10-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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