Last updated: 11/07/2018 11:42:15

A single-centre, randomized, open-label, 3-period crossover study using other inhalers as controls, non-pharmacological intervention, to investigate the operability of novel inhaler in subjects who have not previously used any of the inhalers assessed

GSK study ID
200252
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A single-centre, randomized, open-label, 3-period crossover study using other inhalers as controls, non-pharmacological intervention, to investigate the operability of novel inhaler in subjects who have not previously used any of the inhalers assessed
Trial description: This will be a single-centre, randomized, open-label, 3-period crossover study using other inhalers as controls without any pharmacological intervention.This study is designed to determine the types and frequencies of errors in the inhaler handling technique with ELLIPTA in Japanese adult subjects with no history of regular use of a dry powder inhaler. Each subject will be randomized to one of the six sequences from Sequence 1 to Sequence 6. Subjects will use three different inhalers ELLIPTA, DISKUS, and TURBUHALER one after another in order designated by the allocated sequence. All three inhalers will be assessed on the same day by the same rater. This study will assess the technique in the inhaler handling until just before inhalation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Frequency of each error occurred in the inhaler handling technique in the first use of the inhaler in subjects (hereinafter referred to as “the first attempt”)

Timeframe: Visit 1

Secondary outcomes:

The mean time of handling instruction

Timeframe: Visit 1

Proportion of subjects with any critical errors in the second attempt

Timeframe: Visit 1

Proportion of subjects with any errors in the first attempt, and estimation of the odds ratio for each inhaler (relative to ELLIPTA)

Timeframe: Visit 1

Frequency of each error occurred in the inhaler handling technique in the second use of the inhaler in subjects (hereinafter referred to as “the second attempt”)

Timeframe: Visit 1

Proportion of subjects with any errors in the second attempt

Timeframe: Visit 1

Proportions of subjects who reported each inhaler as the easiest inhaler to operate, along with their reasons

Timeframe: Visit 1

Proportion of subjects with any critical errors in the first attempt, and estimation of the odds ratio for each inhaler (relative to ELLIPTA)

Timeframe: Visit 1

Proportion of subjects who reported each inhaler as the one whose dose indicator was easiest to read

Timeframe: Visit 1

Proportions of subjects who reported each inhaler as the second easiest inhaler to operate

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. Evaluation of operability of a novel inhaler –A study of handling errors in inhalation therapy-naive subjects–. Allergol Immunol. 2014;21(1):146-60.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
June 2013 to July 2013
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
yes
  • Japanese male or female aged 20 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 20 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)
  • 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
Download document(s)
Protocol
Available language(s): English
Download document(s)

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
2013-19-07

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website