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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046069
• Other study ID #: 206455
• Status: Completed
• Start date: February 20, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: March 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Telephone interviews
Qualitative concept elicitation telephone interviews will be conducted in subjects with COPD to explore treatment effectiveness, symptoms, quality of life, and features of treatment that are considered to be most important to them when making treatment choices.
• In-person focus groups
Qualitative concept elicitation in-person focus groups will be conducted in subjects with COPD to explore treatment effectiveness, symptoms, quality of life, and features of treatment that are considered to be most important to them when making treatment choices.
• DCE surveys- cognitive interviews
Draft version of the DCE surveys will be tested with subjects in cognitive interviews to explore the saliency of the attribute choices and assess whether the attributes are understandable, meaningful and comprehensive.
• Modified DCE
The modified DCEs will be piloted with subjects with COPD in each country to refine the underlying design and ensure that information is collected in an efficient way to enable the statistical analysis to be as precise as possible.
• Online DCE survey
An online DCE survey questionnaire will be given to the subjects to identify subject preferences, priorities and treatment goals.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	ICON plc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the key relevant attributes of COPD treatment	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.	Up to 368 hours
Primary	Evaluation of the preferences, priorities and treatment goals of subjects with COPD for inhaled treatments	The probability of choosing one treatment over another will be evaluated using DCE survey questionnaire.	Up to 368 hours
Secondary	Assessment of the relative appeal of different treatment approaches	The burden of COPD, priorities in terms of symptoms and treatment effect, goals and preferences of subjects will be analyzed.	Up to 371 hours
Secondary	Estimation of the relative importance of each attribute	The DCE online survey will be used to assess the relative importance of treatment attributes and priorities.	Up to 371 hours

External Links

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