Last updated: 02/03/2020 18:20:13

Protocol to Characterize Severe Asthma Patient Experience of Treatment Benefit with an anti-IL5 with Clinical Trial Exit Interviews

GSK study ID
204654
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: Protocol to Characterize Severe Asthma Patient Experience of Treatment Benefit with an anti-IL5 with Clinical Trial Exit Interviews
Trial description: Mepolizumab, a monoclonal antibody and interleukin-5 (IL-5) antagonist, has anecdotally demonstrated substantial benefit on asthma and impact of asthma. However, its treatment benefit measured by patient-reported outcomes (PROs) has been inconsistent across asthma-specific PRO endpoints. Mepolizumab is currently being evaluated in a GlaxoSmithKline (GSK) randomized controlled trial 200862 (also known as ‘MUSCA’). The objective of the present study is to characterize patient experience of the treatment benefit of mepolizumab on symptoms, exacerbations, activities, and impacts related to severe asthma based on interviews of subjects completing the MUSCA trial. In addition, the study seeks to compare key ‘concepts’ of treatment benefit with existing PRO measures to identify optimal PROs for future clinical trials.
Subjects will be interviewed in-person or telephonically for 15-20 minutes using a structured interview guide, at their last study visit of MUSCA trial or within 14 days following this visit.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Asthma symptom and exacerbation experience for subjects with severe eosinophilic asthma

Timeframe: One day

Changes in asthma symptoms and impacts, and exacerbation experience over 24 weeks of treatment with mepolizumab or placebo

Timeframe: One day

Mapping of concepts of symptoms and impacts of severe asthma and treatment with mepolizumab to PRO measures and endpoints

Timeframe: One day

Secondary outcomes:
Not applicable
Interventions:
  • Other: Qualitative structured exit-interview
    • Enrollment:
    0
    Primary completion date:
    2016-14-12
    Observational study model:
    Case-Only
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    Evidera
    Study date(s)
    January 2016 to December 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Age 18 years or older at the time of enrollment
    • Participated in GSK's MUSCA clinical trial and completed through Week 24
    • Has a diagnosis of a psychiatric or concurrent medical condition that, in the opinion of the site clinical investigator or coordinator, may affect participation in this study
    • Has a diagnosis or self-report of a cognitive impairment that would interfere with participating in a structured interview
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Age 18 years or older at the time of enrollment
    • Participated in GSK's MUSCA clinical trial and completed through Week 24
    • Willing and able to participate in a 30- to 45-minute discussion at their last study visit (Week 24) or within 14 days following their last study visit, but prior to initiation into a long-term access treatment study with mepolizumab or initiation of another biologic or mepolizumab (once approved)
    • Able to read and understand the language of their country sufficiently to participate in discussion and complete assessments
    • Willing and able to provide written informed consent
    • Willing to be audio-recorded during the discussion
    Exclusion criteria:
    • Has a diagnosis of a psychiatric or concurrent medical condition that, in the opinion of the site clinical investigator or coordinator, may affect participation in this study
    • Has a diagnosis or self-report of a cognitive impairment that would interfere with participating in a structured interview

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    2016-14-12
    Actual study completion date
    2016-14-12

    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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    Access to clinical trial data by researchers
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