Last updated: 04/07/2020 11:50:08

FF/UMEC/VI inhaler: Qualitative analysis and subject preference survey

GSK study ID
206455
See study documents
Clinicaltrials.gov ID
NCT03046069
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: FF/UMEC/VI: Qualitative Interviews and Discrete Choice Experiment(s) Evaluating the Perceived Benefits of the Features of FF/UMEC/VI (single inhaler triple therapy) Treatment in the UK, US and Germany
Trial description: Three main classes of inhaled treatment exist for chronic obstructive pulmonary disease (COPD): Beta2-adrenergic agonists (which may be short (SABA) or long (LABA) acting), long-acting muscarinic acetylcholine receptor antagonists (LAMA), and inhaled corticosteroids (ICS). For subjects at higher risk of exacerbation, treatment with all these three classes of medication is recommended. This study aims to explore the potential utility of a device called single inhaler triple combination or fluticasone furoate/ umeclidinium/ vilanterol (FF/UMEC/VI) inhaler containing all three groups of compound. This is a mixed methods study with a qualitative phase and a quantitative Discrete Choice Experiment (DCE) phase and will be conducted in four stages: qualitative concept elicitation, DCE development, DCE piloting and testing, and conduct of the DCE. The study will conducted in the United Kingdom (UK), United States (US) and Germany and approximately 573 subjects with COPD will be included.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Evaluation of the key relevant attributes of COPD treatment

Timeframe: Up to 368 hours

Evaluation of the preferences, priorities and treatment goals of subjects with COPD for inhaled treatments

Timeframe: Up to 368 hours

Secondary outcomes:

Assessment of the relative appeal of different treatment approaches

Timeframe: Up to 371 hours

Estimation of the relative importance of each attribute

Timeframe: Up to 371 hours

Interventions:
Other: Telephone interviews
Other: In-person focus groups
Other: DCE surveys- cognitive interviews
Other: Modified DCE
Other: Online DCE survey
Enrollment:
634
Observational study model:
Cohort
Primary completion date:
2018-23-02
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
ICON plc
Study date(s)
February 2017 to February 2018
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • Diagnosis of COPD, self-reported.
  • Age: More than or equal to 40 years.
  • Has taken part in any other stage of this study.
  • Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
Inclusion and exclusion criteria
Inclusion criteria:
  • Diagnosis of COPD, self-reported.
  • Age: More than or equal to 40 years.
  • Moderate to severe COPD, indicated by a COPD Assessment Test (CAT) score of greater than or equal to 10 or Modified Medical Research Council (MMRC) score of greater than or equal to 2.
  • Currently prescribed and receiving one of the following treatment types: ICS/LABA; LABA/LAMA; ICS/LABA/LAMA (triple therapy); LAMA.
  • Currently resident in the UK, US or Germany.
  • Adequate written and oral fluency in language of country of residence.
  • Willing and able to understand the study and provide informed consent.
  • Has access to the internet (Cognitive interviews and DCE survey only).
Exclusion criteria:
  • Has taken part in any other stage of this study.
  • Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
  • Any co-morbidity that would inhibit the ability to provide informed consent or allow participation in a telephone of face-to-face interview.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
London, London, United Kingdom, EC4Y 0AY
Status
Study Complete
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Study documents

Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Clinical study report
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
Finalized
Actual primary completion date
2018-23-02
Actual study completion date
2018-23-02

Plain language summaries

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

Additional information about the trial

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Additional information
Results for study 206455 can be found on the GSK Clinical Study Register.
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