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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects included in telephone interviews | Approximately 10 subjects with COPD per country will be included in qualitative concept elicitation 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. |
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| 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. |
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| Subjects included in modified DCEs | Up to 20 subjects with COPD in each country will be included in pilot testing of the modified DCEs. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Estimation of the relative importance of each attribute |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with COPD who may be receiving any combination of dual or triple therapy treatment will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | EC4Y 0AY | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 206455 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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. |
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| Online DCE survey | Other | An online DCE survey questionnaire will be given to the subjects to identify subject preferences, priorities and treatment goals. |
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The DCE online survey will be used to assess the relative importance of treatment attributes and priorities. |
| Up to 371 hours |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |