Health Condition 1: J82- Pulmonary eosinophilia, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
GlaxoSmithKline Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Informed Consent: Prior to commencing any study related activities, participants must be able and willing to provide written informed consent considering the prospective approach. In the retrospective approach, some countries may request a waiver to the Ethical Committees to not sign a new ICF to participants that have already signed an ICF at the moment they were enrolled at the site in the past. This criteria will depend of ethical requirements in each country and will be applied only for countries that will be able to conduct the retrospective approach. b. Participants must already have a physician indication to start treatment with mepolizumab or have already started mepolizumab treatment as an indication to treat severe asthma. Any country that similarly to Turkey has any ethic restriction aspects regarding the patient´s enrolment on the initiation date of mepolizumab, will only enrol patients already using mepolizumab as an inclusion criteria. c. Paper or EMR available for 12-months prior to index date. d. Adults aged 18 years or over.
Exclusion criteria
Exclusion criteria: A participant will not be eligible for inclusion in this study if participated in a clinical trial in which the treatment regimen and/or monitoring was dictated by a protocol during the pre-and post-exposure periods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the overall rates of clinically significant asthma exacerbations in the 12-month pre-exposure and the 12-month post-exposure period with mepolizumab treatmentTimepoint: Compare the overall rates of clinically significant asthma exacerbations in the 12-month pre-exposure and the 12-month post-exposure period with mepolizumab treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Determine patterns of mepolizumab usage including adherence/ persistence, duration of therapy, discontinuation and reasons for discontinuation. 2. Determine and compare the rate of asthma exacerbations stratified by healthcare resource utilization, e.g. those requiring an ED visit and/or hospitalisation with or without ICU stay in the pre- and the 12-month post-exposure period with mepolizumab. 3. Describe change from baseline in OCS dose during the post-exposure period among participants on maintenance OCS. 4. Describe asthma related healthcare resource utilization in the pre- and 12-month postexposure time including count of hospital admissions, ICU stay, ED visits, visits with HCPs, and prescription medication utilization for asthma.Timepoint: 12 month post exposure | — |
Countries
Argentina, Chile, Colombia, India, Russian Federation, Saudi Arabia, Turkey
Contacts
Public ContactDisha Gupta
GSK Pharmaceuticals Limited
Outcome results
None listed