Pulmonary Disease, Chronic ObstructiveNCT03046069
FF/UMEC/VI Inhaler: Qualitative Analysis and Subject Preference Survey
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Telephone interviews, In-person focus groups and DCE surveys- cognitive interviews
- How many people
- 634 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2017to 23 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with COPD who may be receiving any combination of dual or triple therapy treatment will be included in the study.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Telephone interviews, In-person focus groups, DCE surveys- cognitive interviews, Modified DCE, Online DCE survey
- Keywords
- Triple therapy, COPD, DCE, Qualitative
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone interviewsOther
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 groupsOther
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 interviewsOther
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 DCEOther
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 surveyOther
An online DCE survey questionnaire will be given to the subjects to identify subject preferences, priorities and treatment goals.
| Study group | Role | What they receive |
|---|---|---|
| Subjects included in telephone interviews | Approximately 10 subjects with COPD per country will be included in qualitative concept elicitation telephone interviews. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Online DCE survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 368 hours
Secondary outcomes (2)
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.
Measured: Up to 371 hours
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.
Measured: Up to 371 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start20 Feb 2017
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046069
- Sponsor's protocol ID
- 206455
- Status last verified
- Mar 2020
- First submitted
- 6 Feb 2017
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03046069
- Acronym / sponsor ID
- 206455
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Triple therapy, COPD, DCE, Qualitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Subjects included in telephone interviews | – | Other: Telephone interviewsApproximately 10 subjects with COPD per country will be included in qualitative concept elicitation telephone interviews. |
| Subjects included in in-person focus groups | – | Other: In-person focus groups1 in-person focus-group per country including up to 5 subjects with COPD will be included in the qualitative analysis. |
| Subjects included in DCE surveys- cognitive interviews | – | Other: DCE surveys- cognitive interviewsUp to six subjects with COPD in each of the UK, US and Germany will be asked to complete and provide feedback on the surveys. |
| Subjects included in modified DCEs | – | Other: Modified DCEUp to 20 subjects with COPD in each country will be included in pilot testing of the modified DCEs. |
| Subjects included in Final DCE | – | Other: Online DCE survey150 subjects with COPD in each of the UK, US and Germany will be included in the final online market specific DCE survey. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with COPD who may be receiving any combination of dual or triple therapy treatment will be included in the study.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone interviewsQualitative 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. | Other | Subjects included in telephone interviews |
| In-person focus groupsQualitative 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. | Other | Subjects included in in-person focus groups |
| DCE surveys- cognitive interviewsDraft 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. | Other | Subjects included in DCE surveys- cognitive interviews |
| Modified DCEThe 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. | Other | Subjects included in modified DCEs |
| Online DCE surveyAn online DCE survey questionnaire will be given to the subjects to identify subject preferences, priorities and treatment goals. | Other | Subjects included in Final DCE |
Primary outcome
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.
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.
2 secondary outcomes
Assessment of the relative appeal of different treatment approaches
Time frame: Up to 371 hours
Estimation of the relative importance of each attribute
Time frame: Up to 371 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Results for study 206455 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the key relevant attributes of COPD treatment (time frame: Up to 368 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.