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
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2015-10-12
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)

No location data available.

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
Finalized
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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