FF/UMEC/VI Inhaler: Qualitative Analysis and Subject Preference Survey

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: In-person focus groups; Other: Telephone interviews; Other: DCE surveys- cognitive interviews; Other: Online DCE survey; Other: Modified DCE

• Registration Number: NCT03046069
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-08
• Study Start: 2017-02-20
• Primary Completion: 2018-02-23
• Study Completion: 2018-02-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

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).

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects included in in-person focus groups	In-person focus groups	1 in-person focus-group per country including up to 5 subjects with COPD will be included in the qualitative analysis.
Subjects included in telephone interviews	Telephone interviews	Approximately 10 subjects with COPD per country will be included in qualitative concept elicitation telephone interviews.
Subjects included in DCE surveys- cognitive interviews	DCE surveys- cognitive interviews	Up to six subjects with COPD in each of the UK, US and Germany will be asked to complete and provide feedback on the surveys.
Subjects included in Final DCE	Online DCE survey	150 subjects with COPD in each of the UK, US and Germany will be included in the final online market specific DCE survey.
Subjects included in modified DCEs	Modified DCE	Up to 20 subjects with COPD in each country will be included in pilot testing of the modified DCEs.

Primary Outcome Measures

Name	Time	Method
Evaluation of the key relevant attributes of COPD treatment	Up to 368 hours	The key attributes considered to be most important to subjects with COPD when making treatment choices will be assessed using the data from the subject interviews and focus groups.
Evaluation of the preferences, priorities and treatment goals of subjects with COPD for inhaled treatments	Up to 368 hours	The probability of choosing one treatment over another will be evaluated using DCE survey questionnaire.

Secondary Outcome Measures

Name	Time	Method
Assessment of the relative appeal of different treatment approaches	Up to 371 hours	The burden of COPD, priorities in terms of symptoms and treatment effect, goals and preferences of subjects will be analyzed.
Estimation of the relative importance of each attribute	Up to 371 hours	The DCE online survey will be used to assess the relative importance of treatment attributes and priorities.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom