Trial Outcomes & Findings for Effect of Biologicals on Alternative Functions of Eosinophils in Severe Asthma (NCT NCT04520165)
NCT ID: NCT04520165
Last Updated: 2024-10-04
Results Overview
Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater or equal to 80% predicted and/or an improvement of FEV1 greater or equal to 10% and a blood eosinophil count lower than 300 cells/microliter. Markers of remission in the sputum cell profile were investigated.
ACTIVE_NOT_RECRUITING
52 participants
1 year follow-up
2024-10-04
Participant Flow
This observational study was performed at the CHU of Liege, Belgium, between 2014 and 2021
Inclusion criteria included a diagnosis of asthma defined by the Global Initiative for Asthma (http://ginasthma.org/), severe asthma was defined according to European Respiratory Society (ERS)/ American Thoracic Society (ATS) criteria 1. The treatment was stable for all patients at the time of the sampling and the time between baseline and the next evaluation was in average one year
Participant milestones
| Measure |
Remission /Not
Fifty-two severe asthmatics initiated with an anti-IL-5 (51 with Mepolizumab and one with Reslizumab) were recruited from our asthma clinic. Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater than 80% predicted and/or an improvement of FEV1 at least 10% from baseline and a blood eosinophil count lower than 300 cells/microliter.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Biologicals on Alternative Functions of Eosinophils in Severe Asthma
Baseline characteristics by cohort
| Measure |
Remission /Not
n=52 Participants
Fifty-two severe asthmatics initiated with an anti-IL-5 (51 with Mepolizumab and one with Reslizumab) were recruited from our asthma clinic. Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater than 80% predicted and/or an improvement of FEV1 at least 10% from baseline and a blood eosinophil count lower than 300 cells/microliter.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year follow-upPopulation: To compare groups, baseline characteristics were compared with Mann-Whitney U test
Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater or equal to 80% predicted and/or an improvement of FEV1 greater or equal to 10% and a blood eosinophil count lower than 300 cells/microliter. Markers of remission in the sputum cell profile were investigated.
Outcome measures
| Measure |
Remission
n=11 Participants
Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater than 80% predicted and/or an improvement of FEV1 at least 10% from baseline and a blood eosinophil count lower than 300 cells/microliter.
|
No Remission
n=41 Participants
patients that did not fulfilled the remission criteria
|
|---|---|---|
|
Presence of Prognostic Markers of Remission in the Sputum Cell Compartment or Not
Sputum eosinophil count
|
494000 cells/g
Interval 235000.0 to 1663000.0
|
156000 cells/g
Interval 16000.0 to 362000.0
|
|
Presence of Prognostic Markers of Remission in the Sputum Cell Compartment or Not
Sputum neutrophil count
|
798000 cells/g
Interval 437000.0 to 3689000.0
|
943000 cells/g
Interval 544000.0 to 2604000.0
|
|
Presence of Prognostic Markers of Remission in the Sputum Cell Compartment or Not
Sputum macrophage count
|
526000 cells/g
Interval 296000.0 to 988000.0
|
193000 cells/g
Interval 92000.0 to 504000.0
|
|
Presence of Prognostic Markers of Remission in the Sputum Cell Compartment or Not
Sputum lymphocyte count
|
32000 cells/g
Interval 7000.0 to 144000.0
|
4000 cells/g
Interval 0.0 to 31000.0
|
PRIMARY outcome
Timeframe: 1 year follow-upPopulation: To compare groups, baseline characteristics were compared with Mann-Whitney U test
Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater or equal to 80% predicted and/or an improvement of FEV1 greater or equal to 10% and a blood eosinophil count lower than 300 cells/microliter. Markers ( inflammatory mediators) of remission in the sputum were investigated.
Outcome measures
| Measure |
Remission
n=11 Participants
Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater than 80% predicted and/or an improvement of FEV1 at least 10% from baseline and a blood eosinophil count lower than 300 cells/microliter.
|
No Remission
n=41 Participants
patients that did not fulfilled the remission criteria
|
|---|---|---|
|
Presence of Prognostic Markers (Mediators) of Remission in the Sputum or Not
Eotaxin-1
|
71 pg/ml
Interval 56.0 to 204.0
|
54 pg/ml
Interval 0.0 to 87.0
|
|
Presence of Prognostic Markers (Mediators) of Remission in the Sputum or Not
TSLP
|
3.2 pg/ml
Interval 2.4 to 6.5
|
2.2 pg/ml
Interval 1.0 to 3.6
|
|
Presence of Prognostic Markers (Mediators) of Remission in the Sputum or Not
IL-5
|
11.5 pg/ml
Interval 3.5 to 22.2
|
2.7 pg/ml
Interval 1.3 to 4.8
|
|
Presence of Prognostic Markers (Mediators) of Remission in the Sputum or Not
EPX
|
183000 pg/ml
Interval 129000.0 to 342000.0
|
48000 pg/ml
Interval 30000.0 to 99000.0
|
|
Presence of Prognostic Markers (Mediators) of Remission in the Sputum or Not
IgE
|
1200 pg/ml
Interval 400.0 to 2400.0
|
400 pg/ml
Interval 300.0 to 600.0
|
SECONDARY outcome
Timeframe: 1 year follow-upPopulation: To compare groups, baseline characteristics were compared with Mann-Whitey U test
ACT improvement = greater than 19 post-treatment, EPX = Eosinophil peroxidase in the sputum supernatant
Outcome measures
| Measure |
Remission
n=11 Participants
Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater than 80% predicted and/or an improvement of FEV1 at least 10% from baseline and a blood eosinophil count lower than 300 cells/microliter.
|
No Remission
n=41 Participants
patients that did not fulfilled the remission criteria
|
|---|---|---|
|
is EPX in the Sputum of Prognostic Marker of ACT Improvement in the Sputum or Not ?
|
129 ng/ml
Interval 47.0 to 241.0
|
48 ng/ml
Interval 30.0 to 148.0
|
SECONDARY outcome
Timeframe: 1 year follow-upPopulation: To compare groups, baseline characteristics were compared with Mann-Whitney U test
improvement of FEV1 = at least 10% post-treatment IL-5 = interleukin 5 measured in the sputum supernatant
Outcome measures
| Measure |
Remission
n=11 Participants
Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater than 80% predicted and/or an improvement of FEV1 at least 10% from baseline and a blood eosinophil count lower than 300 cells/microliter.
|
No Remission
n=41 Participants
patients that did not fulfilled the remission criteria
|
|---|---|---|
|
Is IL-5 in the Sputum a Prognosis Marker for Improvement of FEV1 Post-treatment or Not ?
|
9 pg/ml
Interval 2.0 to 22.0
|
3 pg/ml
Interval 1.0 to 5.0
|
Adverse Events
Remission /Not
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place