Last updated: 07/28/2020 05:40:05

HO-15-15503 - Qualitative Interviews and Survey: Understanding how the attributes of Relvar/Breo convey patient benefits – Asthma and COPD

GSK study ID
204888
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: HO-15-15503 - Qualitative Interviews and Survey: Understanding how the attributes of Relvar/Breo convey patient benefits – Asthma and COPD
Trial description: The purpose of this study is to identify and evaluate treatment impact, benefits/ disadvantages, preferences and satisfaction/dissatisfaction of RELVAR ELLIPTA (vilanterol + fluticasone furoate) inhaler device directly from subjects who are currently prescribed RELVAR ELLIPTA inhaler device for their Asthma or Chronic Obstructive Pulmonary Disease (COPD) in comparison with other treatments they have taken; and to quantify those benefits and preferences in a structured subject satisfaction survey. This will be investigated by utilizing a mixed methods approach: a sample of subjects will participate in face-to-face interviews in order to provide detailed thematic qualitative data. Another sample will complete a questionnaire (administered online or by phone) that will target related, more detailed quantitative data to answer specific research questions developed from the qualitative data. The study has two phases; (i) qualitative interviews: (ii) quantitative survey, which will be preceded by a cognitive debrief exercise.Stage I will involve semi-structured and open-ended qualitative interviews with asthma and COPD subjects receiving RELVAR ELLIPTA inhaler device treatment. Stage II will comprise of a quantitative survey for the same population; which will be developed from the results of Stage I. RELVAR ELLIPTA inhaler device is registered trademark of the GlaxoSmithKline Group.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Evaluation of qualitative data on benefits, preferences and satisfaction of RELVAR ELLIPTA inhaler device in comparison with other treatments using semi-structured subject interviews

Timeframe: The day of interview.

Evaluation of quantitative data on specific aspects of treatment satisfaction including benefits/ disadvantages, preferences and satisfaction/dissatisfaction using structured subject survey

Timeframe: The day of survey.

Secondary outcomes:
Not applicable
Interventions:
  • Other: Qualitative interviews
  • Other: Quantitative survey
  • Drug: RELVAR ELLIPTA inhaler device
    • Enrollment:
    0
    Primary completion date:
    2017-22-09
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Henrik Svedsater, Helen Doll, Jake Macey, Gail Miles, Lisa Bradshaw, Magdalena Vanya. Evaluating the Impact and Benefits of Fluticasone Furoate/Vilanterol in Individuals with Asthma or COPD: A Mixed-Methods Analysis of Patient Experiences. Adv Ther. 2018;35(9):1378-1399. DOI: 10.1007/s12325-018-0760-7 PMID: 30105658
    Medical condition
    Respiratory Disorders
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
    Collaborators
    None
    Study date(s)
    July 2016 to September 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Inclusion criteria
    • A self-reported diagnosis of Asthma or COPD from a physician Or Asthma-COPD Overlap Syndrome (ACOS)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria
    • A self-reported diagnosis of Asthma or COPD from a physician Or Asthma-COPD Overlap Syndrome (ACOS)
    • Has had asthma, COPD or co-morbid diagnosis for >=1 year
    • Are currently prescribed RELVAR ELLIPTA inhaler device for Asthma or COPD
    • Have been using RELVAR ELLIPTA inhaler device for >=3months
    • >=18 years of age
    • Currently resident in the UK
    • Adequate written and oral fluency in English as judged by the investigator/interviewer
    • Willing and able to provide informed consent
    • Able to attend the focus group/ interview
    • Have access to the internet (Quantitative survey participants only) Exclusion criteria
    • An acute illness or cognitive impairment that in the opinion of the investigator would interfere with the study requirements.
    • Any co-morbidity that would inhibit the ability to provide informed consent or allow participation in a telephone interview/focus group.
    • Taken part in any other stage of phase of this study.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2017-22-09
    Actual study completion date
    2017-22-09

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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