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

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ClinicalTrials.gov Identifier: NCT03046069
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Other: Telephone interviews Other: In-person focus groups Other: DCE surveys- cognitive interviews Other: Modified DCE Other: Online DCE survey

Study Type : Observational
Actual Enrollment : 634 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : February 23, 2018
Actual Study Completion Date : February 23, 2018

Group/Cohort Intervention/treatment
Subjects included in telephone interviews
Approximately 10 subjects with COPD per country will be included in qualitative concept elicitation telephone interviews.
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.

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046069


Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, EC4Y 0AY
Sponsors and Collaborators
GlaxoSmithKline
ICON plc
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03046069     History of Changes
Other Study ID Numbers: 206455
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Triple therapy
COPD
DCE
Qualitative

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive