Trial Outcomes & Findings for Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma (NCT NCT05091385)
NCT ID: NCT05091385
Last Updated: 2026-01-28
Results Overview
Data as transferred from the treatment program questionnaires to the Study Data Sheet. Asthma exacerbations, defined according to the Polish drug programme, is the worsening in asthma requiring (1) use of systemic corticosteroids or (2) increase in dose of OCS for more than 3 days in case of patients who are chronically treated with OCS.
COMPLETED
106 participants
Baseline (before mepolizumab initiation); week 24; week 52
2026-01-28
Participant Flow
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
Not applicable. A uniform, single treatment group throughout the study. No wash-out or run-in periods.
Participant milestones
| Measure |
Severe Asthma Patients Treated With Mepolizumab
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Initially 130 subjects had been recruited, of whom complete data for 106 had been collected, and those subjects were included into the analysis.
Baseline characteristics by cohort
| Measure |
Study Group
n=106 Participants
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
Age, Customized
Age
|
56.6 years
n=106 Participants • Initially 130 subjects had been recruited, of whom complete data for 106 had been collected, and those subjects were included into the analysis.
|
|
Sex: Female, Male
Female
|
77 Participants
n=106 Participants • 106 subjects with complete data were finally analyzed
|
|
Sex: Female, Male
Male
|
29 Participants
n=106 Participants • 106 subjects with complete data were finally analyzed
|
|
Region of Enrollment
Poland
|
106 Participants
n=106 Participants
|
PRIMARY outcome
Timeframe: Baseline (before mepolizumab initiation); week 24; week 52Data as transferred from the treatment program questionnaires to the Study Data Sheet. Asthma exacerbations, defined according to the Polish drug programme, is the worsening in asthma requiring (1) use of systemic corticosteroids or (2) increase in dose of OCS for more than 3 days in case of patients who are chronically treated with OCS.
Outcome measures
| Measure |
Study Group
n=106 Participants
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment
baseline exacerbations number
|
3 number of asthma exacerbations
Interval 2.0 to 5.0
|
|
Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment
Exacerbations at week 24
|
0 number of asthma exacerbations
Interval 0.0 to 1.0
|
|
Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment
Exacerbations at week 52
|
0 number of asthma exacerbations
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Baseline (before mepolizumab initiation); week 24; week 52Data as transferred from the treatment program questionnaires to the Study Data Sheet
Outcome measures
| Measure |
Study Group
n=106 Participants
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
Number Patients Requiring Treatment With Oral Corticosteroids (OCS) at a Chronic Basis (Documented at Qualification for the Treatment and at the 24th and 52nd Week of the Treatment)
Participants requiring chronic OCS treatment of asthma BASELINE
|
70 Participants
|
|
Number Patients Requiring Treatment With Oral Corticosteroids (OCS) at a Chronic Basis (Documented at Qualification for the Treatment and at the 24th and 52nd Week of the Treatment)
Participants requiring chronic OCS treatment of asthma week 24
|
20 Participants
|
|
Number Patients Requiring Treatment With Oral Corticosteroids (OCS) at a Chronic Basis (Documented at Qualification for the Treatment and at the 24th and 52nd Week of the Treatment)
Participants requiring chronic OCS treatment of asthma week 52
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline (before mepolizumab initiation); week 24; week 52Asthma Control Questionnaire (ACQ) is the validated tool aimed to measure the adequacy of asthma control and change in asthma control occurring either spontaneously or as a result of treatment. It is self-administered by patients and assesses asthma symptoms intensity and frequency (5 items) on a 7-point scale (0 through 6; 0=absence, 6= maximum intensity/frequency), with total score being the average of the questions. ACQ score ranges from 0 (minimum) to 6 (maximum). A score of 1.5 or more indicates that a patient has inadequate asthma control. Difference in score of 0.5 or greater is considered clinically important (MCID, minimal clinically important difference).
Outcome measures
| Measure |
Study Group
n=106 Participants
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
ACQ-5 (Asthma Control Questionnaire 5-item) Score
ACQ score value BASELINE
|
3.48 scores on a scale
Interval 2.82 to 4.45
|
|
ACQ-5 (Asthma Control Questionnaire 5-item) Score
ACQ score value week 24
|
1.53 scores on a scale
Interval 0.8 to 2.47
|
|
ACQ-5 (Asthma Control Questionnaire 5-item) Score
ACQ score value week 52
|
1.31 scores on a scale
Interval 0.66 to 2.12
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SECONDARY outcome
Timeframe: Baseline (before mepolizumab initiation); week 24; week 52Asthma Quality of Life Questionnaire (AQLQ) is a disease-specific tool covering both physical and emotional impact of asthma upon the affected subjects' quality of life. This questionnaire has 4 domains: symptoms, activity limitation, emotional function, and environmental stimuli. The AQLQ has been validated in 2 variants: a standard AQLQ consisting of 32 items and a mini-AQLQ containing 15 items. In the national severe asthma treatment program in Poland a 15-item AQLQ is used, as per National Health Fund requirements. Items are scored on a 7-point Likert scale, with score 1 representing maximal impairment and the value of 7 attributed to "no impairment". The total score is calculated as a mean value of all items (a sum of scores divided by 15). A change of \>0.5 points is considered clinically significant. Score below 5 indicates considerable lowering of quality of life in an asthmatic subject and is one of the conditions for inclusion into the reimbursed treatment program.
Outcome measures
| Measure |
Study Group
n=106 Participants
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
AQLQ (Asthma Quality of Life Questionnaire) Score
AQLQ score BASELINE
|
2.47 score points
Interval 1.19 to 3.5
|
|
AQLQ (Asthma Quality of Life Questionnaire) Score
AQLQ score week 24
|
5.8 score points
Interval 4.2 to 6.7
|
|
AQLQ (Asthma Quality of Life Questionnaire) Score
AQLQ score week 52
|
5.3 score points
Interval 4.25 to 6.3
|
SECONDARY outcome
Timeframe: Baseline (before mepolizumab initiation); week 24; week 52Pre-bronchodilator FEV1 (forced expiratory volume in 1 second) is a key indicator in lung funtion testing, measuring the volume of air exhaled from the lungs in the first second of a maximum forced exhalation. FEV1 is commonly used to diagnose and monitor obstructive lung diseases, including asthma. Values below 80% of the predicted value (calculated individually using basing on subject's age, sex, height, weight and ethnicity) indicates narrowing of the airways.
Outcome measures
| Measure |
Study Group
n=106 Participants
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
Pre-bronchodilator FEV1
FEV1 Baseline
|
62 % predicted
Interval 50.0 to 75.0
|
|
Pre-bronchodilator FEV1
FEV1 week 24
|
76.0 % predicted
Interval 60.3 to 85.7
|
|
Pre-bronchodilator FEV1
FEV1 week 52
|
76 % predicted
Interval 62.0 to 85.2
|
SECONDARY outcome
Timeframe: Baseline (before mepolizumab initiation); week 24; week 52Data as transferred from the treatment program questionnaires to the Study Data Sheet
Outcome measures
| Measure |
Study Group
n=106 Participants
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
Blood Eosinophil Counts
Eosinophil count (peripheral blood) BASELINE
|
605 cell per microliter
Interval 430.0 to 800.0
|
|
Blood Eosinophil Counts
Eosinophil count (peripheral blood) week 24
|
60 cell per microliter
Interval 30.0 to 100.0
|
|
Blood Eosinophil Counts
Eosinophil count (peripheral blood) week 52
|
60 cell per microliter
Interval 30.0 to 110.0
|
Adverse Events
Study Group
Serious adverse events
| Measure |
Study Group
n=106 participants at risk
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
miscarriage
|
0.94%
1/106 • Number of events 1 • Throughout the treatment period (weeks 0 through 52)
Two (1.9%) patients were reported to experience adverse events during treatment. One (0.9%) patient experienced a miscarriage after 7th dose of mepolizumab administration. One (0.9%) patient complained of pain in the small joints of the both hands
|
Other adverse events
| Measure |
Study Group
n=106 participants at risk
Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019
|
|---|---|
|
Musculoskeletal and connective tissue disorders
pain in the small joints of both hands
|
0.94%
1/106 • Number of events 1 • Throughout the treatment period (weeks 0 through 52)
Two (1.9%) patients were reported to experience adverse events during treatment. One (0.9%) patient experienced a miscarriage after 7th dose of mepolizumab administration. One (0.9%) patient complained of pain in the small joints of the both hands
|
Additional Information
Marcin Kurowski, MD (PI)
Medical University of Lodz, Dept. of Immunology and Allergy
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place