Last updated: 02/04/2020 15:00:19

HO-13-9058 - Indirect treatment comparison (ITC) of mepolizumab versus omalizumab in the treatment of adults and adolescents (aged >=12 years) with severe asthma

GSK study ID
200227
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-13-9058 - Indirect treatment comparison (ITC) of mepolizumab versus omalizumab in the treatment of adults and adolescents (aged >=12 years) with severe asthma
Trial description: The objective of this study is to assess the comparative efficacy of mepolizumab and omalizumab the treatment of adults and adolescents (aged ≥12 years) with severe asthma, in terms of exacerbations, lung function, health-related quality of life and asthma control. The study is an indirect treatment comparison, using via Frequentist and/or Bayesian approaches, and will be based on a previous systematic literature review.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Exacerbations

Timeframe: 1 year

Secondary outcomes:

Health-related quality of life

Timeframe: Variable - up to 1 year

Asthma control

Timeframe: Variable - up to 1 year

Lung function

Timeframe: Variable - up to 1 year

Interventions:
  • Drug: Omalizumab
  • Drug: Mepolizumab
    • Enrollment:
    0
    Primary completion date:
    2015-10-12
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Cockle S , Stynes G, Gunsoy N, Parks D, Alfonso Cristancho R, Wex J, Bradford E, Albers F, Wilson J. Comparative effectiveness of mepolizumab and omalizumab in severe asthma: an indirect treatment comparison. Respir Med. 2017;123:140-148 .
    Medical condition
    Asthma
    Product
    mepolizumab, omalizumab
    Collaborators
    Not applicable
    Study date(s)
    December 2014 to December 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    none
    • Data from OMA and MEPO randomized controlled clinical trials (RCTs), which enrolled severe asthma patients aged ≥12 years, receiving ≥ 1,000 mcg/day BDP equivalent plus ≥ 1 additional controller and with a documented history of exacerbations, will be included in the ITC. In addition to these criteria, the 3 population criteria are further defined:
    • Inclusion Criteria:
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Data from OMA and MEPO randomized controlled clinical trials (RCTs), which enrolled severe asthma patients aged ≥12 years, receiving ≥ 1,000 mcg/day BDP equivalent plus ≥ 1 additional controller and with a documented history of exacerbations, will be included in the ITC. In addition to these criteria, the 3 population criteria are further defined: Inclusion Criteria: #1: Overlap population:
    • ≥ 2 OCS-treated exacerbation OR ≥ 1 severe exacerbation resulting in hospitalisation in previous 12 months
    • MEPO: OMA-eligible patients from the MEPO included trials, as defined by weight, IgE levels and positive RAST test (4 allergens)
    • OMA: RCTs including patients meeting ≥ 1 OMA country/regional license #2: Expanded overlap population:
    • ≥ 1 exacerbation in the previous 12 months (defined as treatment with OCS or asthma hospitalisation or asthma ED visit) [change from population #1]
    • MEPO: OMA-eligible patients from the MEPO included trials, as defined by weight, IgE levels and positive RAST test (4 allergens)
    • OMA: RCTs including patients meeting ≥ 1 OMA license #3: Licensed population:
    • ≥ 1 exacerbation in the previous 12 months (defined as treatment with OCS or asthma hospitalisation or asthma)
    • MEPO: All patients eligible to receive MEPO (regardless of OMA eligibility) [change from population #2]
    • OMA: RCTs including patients meeting ≥ 1 OMA license Exclusion Criteria: N/A

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
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    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
    2015-10-12
    Actual study completion date
    2015-10-12

    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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