Last updated: 05/23/2024 06:40:08

Rescue medication use among participants with allergic asthma treated with Nucala®

GSK study ID
214148
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: Exacerbations, Rescue Medication & OCS in Patients Diagnosed with Allergic Asthma & Treated with Nucala
Trial description: This study is being conducted to assess the impact of initiating Nucala (mepolizumab) on outcomes among participants with allergic and non-allergic asthma. NUCALA is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Annual rate of asthma exacerbations

Timeframe: 12 months before mepolizumab initiation to 12 months after mepolizumab initiation

Secondary outcomes:

Percentage of participants with any oral corticosteroid (OCS) use

Timeframe: 12 months before mepolizumab initiation to 12 months after mepolizumab initiation

Number of OCS pharmacy claims per participant

Timeframe: 12 months before mepolizumab initiation to 12 months after mepolizumab initiation

Number of participants with any short-acting inhaled beta-agonist (SABA) use

Timeframe: 12 months before mepolizumab initiation to 12 months after mepolizumab initiation

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-03-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Jared Silver, Andrea Steffens, Benjamin Chastek, Arijita Deb. Real-World Effectiveness of Mepolizumab in Patients with Allergic and Non-Allergic Asthma. Journal of Asthma and Allergy. 2024-3;Volume 17: 261-271 DOI: 10.2147/JAA.S444693 PMID: 38544676
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
August 2021 to May 2022
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
6+ years
Accepts healthy volunteers
No
  • Treatment with mepolizumab (a pharmacy fill or administration) between 01-Jan-2016 and 31-Dec-2018 (participant identification period). The index date will be defined as the first date of mepolizumab treatment.
  • Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (baseline period).
  • Mepolizumab treatment (a pharmacy fill or administration) during the baseline period (excluding index date).
  • At least one pharmacy fill for or administration of reslizumab, benralizumab, or dupilumab during the baseline period.
Inclusion and exclusion criteria
Inclusion criteria:
  • Treatment with mepolizumab (a pharmacy fill or administration) between 01-Jan-2016 and 31-Dec-2018 (participant identification period). The index date will be defined as the first date of mepolizumab treatment.
  • Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (baseline period).
  • Continuous enrollment with medical and pharmacy coverage for 12 months following the index date (follow-up period).
  • At least 6 years of age as of the index year.
  • At least 1 non-laboratory medical claim with a diagnosis code for asthma in the primary position during the 12 months prior to and including the index date.
  • At least 2 claims on distinct dates for mepolizumab during first 180 days of the follow-up period (including index date).
Exclusion criteria:
  • Mepolizumab treatment (a pharmacy fill or administration) during the baseline period (excluding index date).
  • At least one pharmacy fill for or administration of reslizumab, benralizumab, or dupilumab during the baseline period.
  • At least one pharmacy fill for or administration of omalizumab, reslizumab, benralizumab, or dupilumab during the follow-up period.
  • Unknown gender.
  • Missing, unknown or other geographic region.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
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
2022-03-05
Actual study completion date
2022-03-05

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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