Last updated: 02/14/2022 11:20:06
Characterization and treatment outcomes of severe eosinophilic asthmatic participants on treatment with mepolizumab
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Characterization of the patient population and the treatment outcomes of severe eosinophilic asthma patients treated with mepolizumab in real-life clinical practice
Trial description: Mepolizumab is a humanized Immunoglobulin G (IgG)1/kappa monoclonal antibody that specifically terminates the survival of eosinophils. Asthma is estimated to affect more than 300 million people worldwide, presenting a major global burden in terms of morbidity, reduced quality of life, mortality, and economic costs. This is a retrospective chart review study which will describe the population type and the clinical treatment outcomes of participants with severe eosinophilic asthma receiving mepolizumab therapy. The study is based on electronic health record data of Finnish participants whose mepolizumab therapy has been initiated at the University Hospitals of Turku, Tampere, Helsinki or Oulu between 01-Jan-2016 and 31-Jan-2019. Data will be collected from medical charts in a pre-established standardized case report form (CRF). Data collection will be performed by healthcare professionals in participating clinics and/or members of the research group.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Demographic characteristics of participants treated with mepolizumab at cohort entry
Timeframe: Day 1
Number of participants with comorbidities at cohort entry
Timeframe: Day 1
Number of participants receiving pharmacotherapy indicated for asthma at cohort entry
Timeframe: Up to 12 months prior to cohort entry
Forced expiratory volume in 1 second (FEV1) (Liters) at cohort entry
Timeframe: Day 1
Forced vital capacity (FVC) (Liters) at cohort entry
Timeframe: Day 1
Eosinophil count (10^9 cells per liter) at cohort entry
Timeframe: Day 1
IgE count (International Units per milliliter) at cohort entry
Timeframe: Day 1
Fractional Concentration of Exhaled Nitric Oxide (FeNO) level (parts per billion) at cohort entry
Timeframe: Day 1
Asthma Quality of Life Questionnaire (AQLQ) score (scores on a scale) at cohort entry
Timeframe: Day 1
Asthma Control Test (ACT) Score (Scores on a scale) at cohort entry
Timeframe: Day 1
Number of participants with exacerbation history at cohort entry
Timeframe: Up to 12 months before cohort entry
Dose of mepolizumab
Timeframe: Up to 24 months
Dosing frequency of mepolizumab
Timeframe: Up to 24 months
Duration of mepolizumab treatment
Timeframe: Up to 24 months
Treatment persistence of mepolizumab
Timeframe: Up to 24 months
Deyo Charlson co-morbidity index at cohort entry
Timeframe: Day 1
Secondary outcomes:
Change from Baseline in FEV1 (Liters)
Timeframe: Baseline and up to 24 months
Change from Baseline in FVC (Liters)
Timeframe: Baseline and up to 24 months
Change from Baseline in eosinophil count (10^9 cells per liter)
Timeframe: Baseline and up to 24 months
Change from Baseline in IgE count (International Units per milliliter)
Timeframe: Baseline and up to 24 months
Change from Baseline in FeNO level (parts per billion)
Timeframe: Baseline and up to 24 months
Change from Baseline in AQLQ score (scores on a scale)
Timeframe: Baseline and up to 24 months
Change from Baseline in ACT Score (Scores on a scale)
Timeframe: Baseline and up to 24 months
Change from Baseline in annual cumulative OCS dose (mg/year)
Timeframe: Baseline and up to 12 months
Change from Baseline in annual number of asthma exacerbations (exacerbations)
Timeframe: Baseline and up to 12 months
Change from Baseline in percentage of OCS-dependent participants
Timeframe: Baseline and up to 12 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-16-03
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Koistinen V, Kauppi P, Idänpään-Heikkilä J, Veijalainen L, Iso-Mustajärvi I, Yli-Saukko-Oja T, Mehtälä J, Viinanen A, Kilpeläinen M. Effectiveness of mepolizumab in patients with severe eosinophilic asthma: results from real-world clinical practice in Finland. J Asthma. 2022;
DOI: https://doi.org/10.1080/02770903.2021.2020813
PMID: 35094632
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2019 to March 2020
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Men and women ≥ 18 years of age with a diagnosis of asthma (J45.xx)
- Mepolizumab treatment initiated between 01-Jan-2016 or after 31-Jan-2019
- Men and women <18 years of age
- Participants without a diagnosis of asthma (J45.xx)
Inclusion and exclusion criteria
Inclusion criteria:
- Men and women ≥ 18 years of age with a diagnosis of asthma (J45.xx)
- Mepolizumab treatment initiated between 01-Jan-2016 or after 31-Jan-2019
Exclusion criteria:
- Men and women <18 years of age
- Participants without a diagnosis of asthma (J45.xx)
- Mepolizumab treatment initiated before 01-Jan-2016 and 31-Jan-2019
- Participant is enrolled in a clinical trial
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
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
Study complete
Actual primary completion date
2020-16-03
Actual study completion date
2020-16-03
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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