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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Telephone interviews; Other: DCE surveys- cognitive interviews; Other: In-person focus groups; Other: Modified DCE; Other: Online DCE survey

Study type: Observational

Funder types: Industry

Identifiers

NCT03046069

206455

Details and patient eligibility

About

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.

Enrollment: 634 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 design

634 participants in 5 patient groups

Subjects included in telephone interviews

Description:

Approximately 10 subjects with COPD per country will be included in qualitative concept elicitation telephone interviews.

Treatment:

Other: Telephone interviews

Subjects included in in-person focus groups

Description:

1 in-person focus-group per country including up to 5 subjects with COPD will be included in the qualitative analysis.

Treatment:

Other: In-person focus groups

Subjects included in DCE surveys- cognitive interviews

Description:

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.

Treatment:

Other: DCE surveys- cognitive interviews

Subjects included in modified DCEs

Description:

Up to 20 subjects with COPD in each country will be included in pilot testing of the modified DCEs.

Treatment:

Other: Modified DCE

Subjects included in Final DCE

Description:

150 subjects with COPD in each of the UK, US and Germany will be included in the final online market specific DCE survey.

Treatment:

Other: Online DCE survey