Trial Outcomes & Findings for Impulse Oscillometry Measurements in Severe Eosinophilic Asthmatics Before and After Anti-IL-5 Factor Initiation (NCT NCT05147155)
NCT ID: NCT05147155
Last Updated: 2025-02-24
Results Overview
Estimate AX after 26 weeks from mepolizumab initiation. AX, the area of reactance derived from impulse oscillometry, represents the elastic and inertial properties of the lungs. Measurements were taken at Week 26 using standard protocols. Values are reported in kPa/L and analyzed following guidelines from the European Respiratory Society.
COMPLETED
130 participants
26 weeks
2025-02-24
Participant Flow
Participant milestones
| Measure |
Severe Asthma Patients
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
Control Group 1
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
50
|
40
|
|
Overall Study
COMPLETED
|
40
|
50
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=130 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=40 Participants
|
40 Participants
n=50 Participants
|
30 Participants
n=40 Participants
|
100 Participants
n=130 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=40 Participants
|
10 Participants
n=50 Participants
|
10 Participants
n=40 Participants
|
30 Participants
n=130 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 12 • n=40 Participants
|
58 years
STANDARD_DEVIATION 11 • n=50 Participants
|
56 years
STANDARD_DEVIATION 14 • n=40 Participants
|
58 years
STANDARD_DEVIATION 13 • n=130 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=40 Participants
|
35 Participants
n=50 Participants
|
24 Participants
n=40 Participants
|
86 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=40 Participants
|
15 Participants
n=50 Participants
|
16 Participants
n=40 Participants
|
44 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=40 Participants
|
50 Participants
n=50 Participants
|
40 Participants
n=40 Participants
|
130 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=40 Participants
|
50 Participants
n=50 Participants
|
40 Participants
n=40 Participants
|
130 Participants
n=130 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=130 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Greece
|
40 participants
n=40 Participants
|
50 participants
n=50 Participants
|
40 participants
n=40 Participants
|
130 participants
n=130 Participants
|
|
Early-onset asthma
|
7 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=40 Participants
|
8 Participants
n=130 Participants
|
PRIMARY outcome
Timeframe: 0 monthsMeasurements of R5 at baseline (pre-mepolizumab initiation). R5 was assessed using impulse oscillometry. The values are reported in kPa/L/s and were analyzed following the guidelines of the European Respiratory Society
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Airway Resistance at 5 Hz (R5) at Baseline (Pre-mepolizumab Initiation)
|
0.39 kPa/L/s
Standard Deviation 0.12
|
0.43 kPa/L/s
Standard Deviation 0.16
|
0.51 kPa/L/s
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: 0 monthsMeasurement of R20 at baseline - mepolizumab initiation. R20 was measured using impulse oscillometry, representing airway resistance at 20 Hz. Values are reported in kPa/L/s, and assessments were conducted according to the standards outlined by the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Airway Resistance at 20 Hz (R20) at Baseline
|
0.3 kPa/L/s
Standard Deviation 0.07
|
0.3 kPa/L/s
Standard Deviation 0.09
|
0.4 kPa/L/s
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 0 monthsMeasurement of R5-R20 at baseline. R5-R20 represents the difference between airway resistance at 5 Hz (R5) and 20 Hz (R20), measured using impulse oscillometry. This measure reflects peripheral airway resistance. Assessments were conducted at baseline, and values are reported in kPa/L/s following guidelines from the European Respiratory Society
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Difference Between Airway Resistance at 5 Hz (R5) and 20 Hz (R20) at Baseline / (R5-R20) at Baseline
|
0.05 kPa/L/s
Standard Deviation 0.04
|
0.09 kPa/L/s
Standard Deviation 0.08
|
0.12 kPa/L/s
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 0 monthsMeasurement of AX at baseline. AX, the area of reactance derived from impulse oscillometry, represents the elastic and inertial properties of the lungs. Measurements were taken at baseline using standard protocols. Values are reported in kPa/L and analyzed following guidelines from the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Reactance Area (AX) at Baseline
|
0.5 kPa/L
Standard Deviation 0.5
|
0.7 kPa/L
Standard Deviation 0.6
|
1.2 kPa/L
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 0 monthsMeasurement of Fres at Baseline. Fres, the resonant frequency, is the point where the reactance of the respiratory system equals zero, indicating the balance between elastic and inertial forces in the lungs. Measurements were taken at baseline using impulse oscillometry. Values are reported in Hz and analyzed following guidelines from the European Respiratory Society
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Resonant Frequency (Fres) at Baseline
|
9 Hz
Standard Deviation 5
|
16 Hz
Standard Deviation 7
|
35 Hz
Standard Deviation 17
|
PRIMARY outcome
Timeframe: 0 monthsMeasurement of X5 at Baseline. X5, the respiratory reactance at 5 Hz, is a measure of the elastic properties of the lungs and the peripheral airways. It indicates how easily the lungs expand and contract during breathing. Measurements were taken at baseline using impulse oscillometry, with values expressed in kPa/L. Assessments followed European Respiratory Society guidelines. X5 is negative because the lungs store energy due to their elasticity, which results in a delayed response of airflow relative to pressure changes. This behavior is characteristic of a capacitive system, where elastic forces dominate at low frequencies. A less negative X5 means that the lung's elastic recoil is reduced, leading to decreased resistance to expansion.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Respiratory Reactance at 5 Hz (X5) at Baseline
|
-0.08 kPa/L
Standard Deviation 0.02
|
-0.09 kPa/L
Standard Deviation 0.04
|
-0.1 kPa/L
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: 4 weeksEstimate the airway resistance measured at the 5 Hz frequency (R5) after four weeks from mepolizumab initiation (only severe uncontrolled asthma patients received mepolizumab). R5 was assessed using impulse oscillometry. The values are reported in kPa/L/s and were analyzed following the guidelines of the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Airway Resistance at 5 Hz (R5) at Week 4.
|
0.3 kPa/L/s
Standard Deviation 0.1
|
0.43 kPa/L/s
Standard Deviation 0.16
|
0.49 kPa/L/s
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: 4 weeksEstimate the airway resistance measured at the 20 Hz frequency (R20) after four weeks from mepolizumab initiation. R20 was measured using impulse oscillometry, representing airway resistance at 20 Hz. Values are reported in kPa/L/s, and assessments were conducted according to the standards outlined by the European Respiratory Society
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Airway Resistance at 20 Hz (R20) at Week 4.
|
0.3 kPa/L/s
Standard Deviation 0.09
|
0.3 kPa/L/s
Standard Deviation 0.07
|
0.4 kPa/L/s
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: 4 weeksAfter four weeks of mepolizumab initiation, estimate the small airway resistance (R5- R20). R5-R20 represents the difference between airway resistance at 5 Hz (R5) and 20 Hz (R20), measured using impulse oscillometry. This measure reflects peripheral airway resistance. Assessments were conducted after 4 weeks from mepolizumab initiation, and values are reported in kPa/L/s following guidelines from the European Respiratory Society
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Difference Between Airway Resistance at 5 Hz (R5) and 20 Hz (R20) at Week 4/ R5-R20 at Week 4.
|
0.04 kPa/L/s
Standard Deviation 0.03
|
0.09 kPa/L/s
Standard Deviation 0.08
|
0.10 kPa/L/s
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: 4 weeksEstimate the AX after four weeks from mepolizumab initiation. AX, the area of reactance derived from impulse oscillometry, represents the elastic and inertial properties of the lungs. Measurements were taken at Week 4 using standard protocols. Values are reported in kPa/L and analyzed following guidelines from the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Reactance Area (AX) at Week 4
|
0.5 kPa/L
Standard Error 0.5
|
0.7 kPa/L
Standard Error 0.6
|
0.7 kPa/L
Standard Error 0.6
|
PRIMARY outcome
Timeframe: 4 weeksEstimate Fres after four weeks from mepolizumab initiation. Fres, the resonant frequency, is the point at which the reactance of the respiratory system equals zero, reflecting the balance between the elastic and inertial forces of the lungs. Measurements were taken at Week 4 using impulse oscillometry. Values are expressed in Hz and analyzed in accordance with European Respiratory Society guidelines.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Resonant Frequency (Fres) at Week 4.
|
10 Hz
Standard Deviation 5
|
16 Hz
Standard Deviation 7
|
17 Hz
Standard Deviation 5
|
PRIMARY outcome
Timeframe: 4 weeksEstimate X5 after four weeks from mepolizumab initiation. X5, the respiratory reactance at 5 Hz, is a measure of the elastic properties of the lungs and peripheral airways, reflecting the ability of the respiratory system to expand and contract. Measurements were taken at Week 4 using impulse oscillometry. Values are reported in kPa/L and were analyzed according to European Respiratory Society guidelines. X5 is negative because the lungs store energy due to their elasticity, which results in a delayed response of airflow relative to pressure changes. This behavior is characteristic of a capacitive system, where elastic forces dominate at low frequencies. A less negative X5 means that the lung's elastic recoil is reduced, leading to decreased resistance to expansion.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Respiratory Reactance at 5 Hz (X5) at Week 4.
|
-0.08 kPa/L
Standard Deviation 0.04
|
-0.09 kPa/L
Standard Deviation 0.04
|
-0.1 kPa/L
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 12 weeksEstimate the airway resistance measured at the 5 Hz frequency (R5) after 12 weeks from the mepolizumab initiation. R5 was assessed using spirometry with impulse oscillometry. The values are reported in kPa/L/s and were analyzed following the guidelines of the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Airway Resistance at 5 Hz (R5) at Week 12
|
0.3 kPa/L/s
Standard Deviation 0.1
|
0.43 kPa/L/s
Standard Deviation 0.16
|
0.51 kPa/L/s
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: 12 weeksEstimate the airway resistance measured at the 20 Hz frequency (R20) after 12 weeks from mepolizumab initiation. R20 was measured using impulse oscillometry, representing airway resistance at 20 Hz. Values are reported in kPa/L/s, and assessments were conducted according to the standards outlined by the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Airway Resistance at 20 Hz (R20) at Week 12
|
0.3 kPa/L/s
Standard Deviation 0.09
|
0.3 kPa/L/s
Standard Deviation 0.07
|
0.4 kPa/L/s
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 12 weeksEstimate small airway resistance (R5-R20) after 12 weeks from mepolizumab initiation. R5-R20 represents the difference between airway resistance at 5 Hz (R5) and 20 Hz (R20), measured using impulse oscillometry. This measure reflects peripheral airway resistance. Assessments were conducted at week 12 after mepolizuamb initiation, and values are reported in kPa/L/s following guidelines from the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Difference Between Airway Resistance at 5 Hz (R5) and 20 Hz (R20) at Week 12 / R5-R20 at Week 12
|
0.04 kPa/L/s
Standard Deviation 0.03
|
0.09 kPa/L/s
Standard Deviation 0.08
|
0.13 kPa/L/s
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: 12 weeksEstimate the AX after 12 weeks from mepolizumab initiation. AX, the area of reactance derived from impulse oscillometry, represents the elastic and inertial properties of the lungs. Measurements were taken at Week 12 using standard protocols. Values are reported in kPa/L and analyzed following guidelines from the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Reactance Area (AX) at Week 12
|
0.5 kPa/L
Standard Deviation 0.5
|
0.7 kPa/L
Standard Deviation 0.6
|
0.7 kPa/L
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 12 weeksEstimate Fres after12 weeks from mepolizumab initiation. Fres, the resonant frequency, is the point at which the reactance of the respiratory system equals zero, reflecting the balance between the elastic and inertial forces of the lungs. Measurements were taken at Week 4 using impulse oscillometry. Values are expressed in Hz and analyzed in accordance with European Respiratory Society guidelines.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Resonant Frequency (Fres) at Week 12
|
10 Hz
Standard Deviation 5
|
16 Hz
Standard Deviation 7
|
17 Hz
Standard Deviation 6
|
PRIMARY outcome
Timeframe: 12 weeksEstimate X5 after 12 weeks from mepolizumab initiation. X5, the respiratory reactance at 5 Hz, measures the elastic properties of the lungs and peripheral airways, reflecting the ability of the respiratory system to expand and contract. Measurements were taken at Week 12 using impulse oscillometry. Values are reported in kPa/L and analyzed according to European Respiratory Society guidelines. X5 is negative because the lungs store energy due to their elasticity, which results in a delayed response of airflow relative to pressure changes. This behavior is characteristic of a capacitive system, where elastic forces dominate at low frequencies. A less negative X5 means that the lung's elastic recoil is reduced, leading to decreased resistance to expansion.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Respiratory Reactance at 5 Hz (X5) at Week 12
|
-0.08 kPa/L
Standard Deviation 0.04
|
-0.09 kPa/L
Standard Deviation 0.04
|
-0.1 kPa/L
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 26 weeksEstimate the airway resistance measured at the 5 Hz frequency (R5) after 26 weeks from the initiation of mepolizumab. R5 was assessed using spirometry with impulse oscillometry. The values are reported in kPa/L/s and were analyzed following the guidelines of the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Airway Resistance at 5 Hz (R5) at Week 26.
|
0.3 kPa/L/s
Standard Deviation 0.1
|
0.43 kPa/L/s
Standard Deviation 0.16
|
0.41 kPa/L/s
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 26 weeksEstimate the airway resistance measured at the 20 Hz frequency (R20) after 26 weeks from mepolizumab initiation. R20 was measured using impulse oscillometry, representing airway resistance at 20 Hz. Values are reported in kPa/L/s, and assessments were conducted according to the standards outlined by the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Airway Resistance at 20 Hz (R20) at Week 26.
|
0.3 kPa/L/s
Standard Deviation 0.09
|
0.3 kPa/L/s
Standard Deviation 0.07
|
0.4 kPa/L/s
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 26 weeksEstimate the small airway resistance (R5-R20) after 26 weeks from mepolizumab initiation. R5-R20 represents the difference between airway resistance at 5 Hz (R5) and 20 Hz (R20), measured using impulse oscillometry. This measure reflects peripheral airway resistance. Assessments were conducted at Week 26 after mepolizumab initiation, and values are reported in kPa/L/s following guidelines from the European Respiratory Society
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Difference Between Airway Resistance at 5 Hz (R5) and 20 Hz (R20) at Week 26 / R5-R20 at Week 26.
|
0.04 kPa/L/s
Standard Deviation 0.03
|
0.09 kPa/L/s
Standard Deviation 0.08
|
0.03 kPa/L/s
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: 26 weeksEstimate AX after 26 weeks from mepolizumab initiation. AX, the area of reactance derived from impulse oscillometry, represents the elastic and inertial properties of the lungs. Measurements were taken at Week 26 using standard protocols. Values are reported in kPa/L and analyzed following guidelines from the European Respiratory Society.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Reactance Area (AX) at Week 26.
|
0.5 kPa/L
Standard Deviation 0.5
|
0.7 kPa/L
Standard Deviation 0.6
|
0.6 kPa/L
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 26 weeksEstimate Fres after 26 weeks from mepolizumab initiation. Fres, the resonant frequency, is the point at which the reactance of the respiratory system equals zero, reflecting the balance between the elastic and inertial forces of the lungs. Measurements were taken at Week 26 using impulse oscillometry. Values are expressed in Hz and analyzed in accordance with European Respiratory Society guidelines.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Resonant Frequency (Fres) at Week 26.
|
10 Hz
Standard Deviation 5
|
16 Hz
Standard Deviation 7
|
17 Hz
Standard Deviation 6
|
PRIMARY outcome
Timeframe: 26 weeksEstimate X5 after 26 weeks from mepolizumab initiation. X5, the respiratory reactance at 5 Hz, reflects the elastic properties of the lungs and peripheral airways, indicating the ability of the respiratory system to expand and contract. Measurements were taken at Week 26 using impulse oscillometry. Values are reported in kPa/L and were analyzed following European Respiratory Society guidelines. X5 is negative because the lungs store energy due to their elasticity, which results in a delayed response of airflow relative to pressure changes. This behavior is characteristic of a capacitive system, where elastic forces dominate at low frequencies. A less negative X5 means that the lung's elastic recoil is reduced, leading to decreased resistance to expansion.
Outcome measures
| Measure |
Control Group 1
n=50 Participants
Control group 1 will be a set of 50 healthy individuals matched for age and gender
|
Control Group 2
n=40 Participants
Control group 2 will be a set of 40 patients with severe well-controlled asthma requiring high dose ICS/LABA combination therapy from becoming uncontrolled, as previously defined, matched for age and gender.
|
Severe Asthma Patients
n=40 Participants
The sample will consist of 40 patients between 18 and 82 years of age with uncontrolled severe eosinophilic asthma despite receiving high dose ICS/LABA combination therapy who will receive mepolizumab, which will be administered as a 100-mg subcutaneous dose every four weeks
Mepolizumab: This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.
|
|---|---|---|---|
|
Respiratory Reactance at 5 Hz (X5) at Week 26.
|
-0.08 kPa/L
Standard Deviation 0.04
|
-0.09 kPa/L
Standard Deviation 0.04
|
-0.08 kPa/L
Standard Deviation 0.1
|
Adverse Events
Severe Asthma Patients
Control Group 1
Control Group 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Research Committee - Special Account for Research Grants University of Thessaly
University of Thessaly
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place