Clinical trial NCT03046069: FF/UMEC/VI Inhaler: Qualitative Analysis and Subject Preference Survey
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Triple therapy
COPD
DCE
Qualitative
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2017-02-08
Enrollment: 634
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with COPD who may be receiving any combination of dual or triple therapy treatment will be included in the study.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Evaluation of the key relevant attributes of COPD treatment
timeFrame: Up to 368 hours
measure: Evaluation of the preferences, priorities and treatment goals of subjects with COPD for inhaled treatments
timeFrame: Up to 368 hours
Secondary outcomes:
measure: Assessment of the relative appeal of different treatment approaches
timeFrame: Up to 371 hours
measure: Estimation of the relative importance of each attribute
timeFrame: Up to 371 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: