Last updated: 03/09/2026 10:50:32
Nucala Impact in Pediatric and Adolescent
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Association of Mepolizumab with Asthma-Related Outcomes in Pediatric and Adolescent Patients with Severe Asthma: A Pre/Post Assessment of Oral Corticosteroid and Asthma Medication Use, Asthma Exacerbations, and Healthcare Resource Utilization in the United States
Trial description: This is a retrospective pre-post study design, used to evaluate differences in Oral Corticosteroid (OCS) use, asthma exacerbations, Short-Acting Beta Agonist (SABA) use, and Healthcare Resource Utilization (HRU) before and after mepolizumab initiation among pediatric and adolescent participants with severe asthma in the United States (US).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean number of OCS dispensing before and after mepolizumab initiation
Timeframe: 12 months pre- and 12 months post-dose
Total number of inpatient/emergency department (IP/ED)-defined asthma exacerbations
Timeframe: 12 months pre- and 12 months post-dose
Total number of SCS-defined asthma exacerbations
Timeframe: 12 months pre- and 12 months post-dose
Secondary outcomes:
Number and percentage of participants receiving greater than or equal to (≥)1 OCS
Timeframe: 12 months pre- and 12 months post-dose
Mean number of OCS bursts Per Patient Year (PPY)
Timeframe: 12 months pre- and 12 months post-dose
Number and percentage of participants with chronic OCS use
Timeframe: 12 months pre- and 12 months post-dose
Number and percentage of participants with maintenance OCS use
Timeframe: 12 months pre- and 12 months post-dose
Mean daily dose of OCS dispensing
Timeframe: 12 months pre- and 12 months post-dose
Number and percentage of participants with ≥1 SABA canister
Timeframe: 12 months pre- and 12 months post-dose
Mean number of SABA canisters
Timeframe: 12 months pre- and 12 months post-dose
All-cause related HRU
Timeframe: 12 months pre- and 12 months post-dose
Asthma related HRU
Timeframe: 12 months pre- and 12 months post-dose
Asthma exacerbation related HRU
Timeframe: 12 months pre- and 12 months post-dose
OCS use among pediatric (6-11 years) and adolescent (12-17 years) participants
Timeframe: 12 months pre- and 12 months post-dose
Asthma exacerbations among pediatric (6-11 years) and adolescent (12-17 years) participants
Timeframe: 12 months pre- and 12 months post-dose
SABA use among pediatric (6-11 years) and adolescent (12-17 years) participants
Timeframe: 12 months pre- and 12 months post-dose
HRU among pediatric (6-11 years) and adolescent (12-17 years) participants
Timeframe: 12 months pre- and 12 months post-dose
Interventions:
Drug: Mepolizumab
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2024-28-02
Time perspective:
Retrospective
Clinical publications:
Hernandez M, Corbridge T, Laliberte F, Mahendran M, Hilts A, Zhang K, et al. . Real-world impact of mepolizumab on pediatric and adolescent patients with severe asthma. J Allergy Clin Immunol Global. 2026-3;5(2): 100638. doi:10.1016/j.jacig.2025.100638 https://doi.org/10.1016/j.jacig.2025.100638
PMID: 41660046
DOI: 10.1016/j.jacig.2025.100638
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
August 2023 to February 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6 - 17 Years
Accepts healthy volunteers
No
- Greater than or equal to (≥)1 medical or pharmacy claim for mepolizumab after October 1, 2016
- 12 months of continuous eligibility prior to the index date
- ≥1 diagnosis of any of the following conditions in the primary or secondary position at any time during the study period:
- a. Active tuberculosis
Inclusion and exclusion criteria
Inclusion criteria:
- Greater than or equal to (≥)1 medical or pharmacy claim for mepolizumab after October 1, 2016
- 12 months of continuous eligibility prior to the index date
- 12 months of continuous eligibility after the index date
- ≥1 diagnosis of asthma in the primary or secondary position during the pre-mepolizumab period or on index date
- ≥2 medical or pharmacy claims for mepolizumab within the first 6 months on or after the index date
Exclusion criteria:
- ≥1 diagnosis of any of the following conditions in the primary or secondary position at any time during the study period: a. Active tuberculosis b. Cystic fibrosis
- ≥1 medical or pharmacy claim for mepolizumab at any time prior to the index date
- ≥1 medical or pharmacy claim for omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab during the post-mepolizumab period
Trial location(s)
No location data available.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
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
2024-28-02
Actual study completion date
2024-28-02
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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