Last updated: 09/30/2026 12:44:36

TYREX: Real-World Long-Term Evolution of Severe Asthma Management in Spain with Mepolizumab Treatment

GSK study ID
222693
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: TYREX: Observational study of the impacT of 5 YeaRs’ EXperience blocking IL-5 with mepolizumab in the evolution of severe asthma management
Trial description: This real-world study looks at adult participants in Spain who have severe asthma and are treated with mepolizumab. The study aims to understand the typical characteristics of these participants, their treatment patterns, and how their health changes over time in routine medical practice.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Participants characterized by Baseline demographics

Timeframe: At Baseline

Number of Participants characterized by Clinical features

Timeframe: At Baseline

Number of Participants characterized by Patient-reported outcomes

Timeframe: At Baseline

Treatment patterns in severe asthma patients treated with mepolizumab

Timeframe: At Baseline

Secondary outcomes:

Proportion of participants achieving Clinical Remission (no clinically significant exacerbations in last 12 months; no oral corticosteroid use for asthma; Asthma Control Test ≥20; lung function stabilization per protocol definition)

Timeframe: 12 months post-index for all participants and at 5 years for the subgroup with greater than (>) 5 years of follow-up

Forced Expiratory Volume in the first second, Exacerbations, Oral corticosteroids, Symptoms (FEOS) score and FEOS ratio

Timeframe: 12 months post-index for all participants and at 5 years for the subgroup with >5 years of follow-up

Exacerbations, ACT, Systemic Corticosteroids and Obstruction (EXACTO) score

Timeframe: 12 months post-index for all participants and at 5 years for the subgroup with >5 years of follow-up

Change in Forced Expiratory Volume in 1 Second (FEV1) (absolute and percent predicted; pre- and post-bronchodilator when available)

Timeframe: Baseline, 12 months post-index for all participants and at 5 years for the subgroup with >5 years of follow-up

Change in annualized rate of clinically significant asthma exacerbations (composite and severity-specific per protocol)

Timeframe: Baseline, 12 months post-index for all participants and at 5 years for the subgroup with >5 years of follow-up

Change in oral corticosteroid consumption (dose and proportion on maintenance oral corticosteroids; withdrawal and reduction metrics)

Timeframe: Baseline, 12 months post-index for all participants and at 5 years for the subgroup with >5 years of follow-up

Change in Asthma Control Test score (including minimum clinically important difference and proportion achieving Asthma Control Test >20)

Timeframe: Baseline, 12 months post-index for all participants and at 5 years for the subgroup with >5 years of follow-up

Change in blood eosinophil levels

Timeframe: Baseline, 12 months post-index for all participants and at 5 years for the subgroup with >5 years of follow-up

Change in fractional exhaled nitric oxide

Timeframe: Baseline, 12 months post-index for all participants and at 5 years for the subgroup with >5 years of follow-up

Healthcare resource use related to inadequate asthma control (e.g., emergency room visits, hospitalizations, intensive care unit admissions, visit types and lengths as per protocol schedule)

Timeframe: Baseline, 12 months post-index for all participants and at 5 years for the subgroup with >5 years of follow-up

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2026-10-03
Observational study model:
Case-Control
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
September 2024 to March 2026
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Adults greater than or equal to (>=) 18 years.
  • Investigator diagnosis of severe asthma.
  • Participation in an interventional trial or use of another biologic for severe asthma in the 12 months before mepolizumab initiation that could alter baseline clinical status (except omalizumab where direct switch is acceptable per protocol).
  • Diagnosis of eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, or chronic obstructive pulmonary disease at any time during the study period.
Inclusion and exclusion criteria
Inclusion criteria:

    Adults greater than or equal to (>=) 18 years.

    • Investigator diagnosis of severe asthma.
    • Treated with add-on mepolizumab for severe asthma for >=12 consecutive months before the data collection period.
    • Medical record data available to address the study primary and secondary objectives, including mepolizumab prescription information over follow-up for at least 12 months after index date (first dose).
Exclusion criteria:

    Participation in an interventional trial or use of another biologic for severe asthma in the 12 months before mepolizumab initiation that could alter baseline clinical status (except omalizumab where direct switch is acceptable per protocol).

    • Diagnosis of eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, or chronic obstructive pulmonary disease at any time during the study period.
    • Concomitant conditions associated with high healthcare resource use (examples provided in protocol include advanced-stage tumors with metastasis or advanced-stage conditions requiring palliative care).

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Finalized
Actual primary completion date
2026-10-03
Actual study completion date
2026-10-03

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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