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

NCT03046069 | Completed

• 1 other identifier: 206455
• Study Type: observational
• Target: 634
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Triple therapy; COPD; DCE; Qualitative

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Assessment of the relative appeal of different treatment approaches

  Up to 371 hours

• Estimation of the relative importance of each attribute

  Up to 371 hours

Study Arms (5)

Subjects included in telephone interviews

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

Other: Telephone interviews

Subjects included in 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.

Other: In-person focus groups

Subjects included in 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.

Other: DCE surveys- cognitive interviews

Subjects included in modified DCEs

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

Other: Modified DCE

Subjects included in Final DCE

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

Other: Online DCE survey

Interventions

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.

Subjects included in telephone interviews

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.

Subjects included in in-person focus groups

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.

Subjects included in DCE surveys- cognitive interviews

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.

Subjects included in modified DCEs

Online DCE survey OTHER

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

Subjects included in Final DCE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• ICON plc: collaborator

Study Sites (1)

GSK Investigational Site

London, EC4Y 0AY, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 8, 2017
• Study Start: February 20, 2017
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

GB (1)