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NCT Number: NCT03046069

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

London, EC4Y 0AY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone interviews

Other

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

Other

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

Other

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

Other

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

Other

An online DCE survey questionnaire will be given to the subjects to identify subject preferences, priorities and treatment goals.

Primary outcomes

  1. Evaluation of the key relevant attributes of COPD treatment

    Time frame: 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.

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

    Time frame: Up to 368 hours

    The probability of choosing one treatment over another will be evaluated using DCE survey questionnaire.

Secondary outcomes

  1. Assessment of the relative appeal of different treatment approaches

    Time frame: Up to 371 hours

    The burden of COPD, priorities in terms of symptoms and treatment effect, goals and preferences of subjects will be analyzed.

  2. Estimation of the relative importance of each attribute

    Time frame: Up to 371 hours

    The DCE online survey will be used to assess the relative importance of treatment attributes and priorities.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • ICON plc

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2017
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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