Trial Outcomes & Findings for Effectiveness of Anti-IL-5/IL5R Inhibitors (NCT NCT06239441)
NCT ID: NCT06239441
Last Updated: 2024-10-28
Results Overview
Percentage of subjects achieving response to IL5/IL5R antagonists. A response to treatment was defined as a reduction of asthma exacerbations of at least 50% or a 50% or higher reduction of the OCS doses for steroid dependant patients in the year following the initiation of an IL5/IL5R antagonist compared to the year preceding the initiation of the treatment.
COMPLETED
108 participants
one year
2024-10-28
Participant Flow
Participant milestones
| Measure |
RCT in Group
Subjects who were aged 75 years or younger, had a smoking history of less than 10 pack-year, a FEV1 of less than 80% of the predicted value along with FEV1 reversibility of at least 12% and 200 ml.
|
RCT Out Group
Subjects who did not meet one of those criteria:
age 75 or younger FEV1 less than 80% FEV1 reversibility after bronchodilator of at least 12% and 200ml.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
86
|
|
Overall Study
COMPLETED
|
22
|
86
|
|
Overall Study
NOT COMPLETED
|
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 |
Randomized Clinical Trial (RCT) in Group
n=22 Participants
Subjects who were aged 75 years or younger, had a smoking history of less than 10 pack-year, a forced expiratory volume in one second (FEV1) of less than 80% of the predicted value along with FEV1 reversibility of at least 12% and 200 ml.
|
Randomized Clinical Trial (RCT) Out Group
n=86 Participants
Subjects who did not meet one of those criteria:
age 75 or younger FEV1 less than 80% FEV1 reversibility after bronchodilator of at least 12% and 200ml.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 12.5 • n=22 Participants
|
59.6 years
STANDARD_DEVIATION 13.6 • n=86 Participants
|
58.7 years
STANDARD_DEVIATION 13.4 • n=108 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=22 Participants
|
51 Participants
n=86 Participants
|
64 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=22 Participants
|
35 Participants
n=86 Participants
|
44 Participants
n=108 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
22 participants
n=22 Participants
|
86 participants
n=86 Participants
|
108 participants
n=108 Participants
|
|
Forced expiratory volume in one second (FEV1) pre bronchodilator (BD)
|
1.63 Litres
STANDARD_DEVIATION 0.54 • n=22 Participants
|
1.81 Litres
STANDARD_DEVIATION 0.86 • n=86 Participants
|
1.73 Litres
STANDARD_DEVIATION 0.76 • n=108 Participants
|
|
Asthma duration
|
25.6 years
STANDARD_DEVIATION 16.6 • n=22 Participants
|
22.9 years
STANDARD_DEVIATION 18.9 • n=86 Participants
|
23.8 years
STANDARD_DEVIATION 18.5 • n=108 Participants
|
|
Atopy
|
19 participants
n=22 Participants
|
55 participants
n=86 Participants
|
74 participants
n=108 Participants
|
|
Daily dose of inhaled corticosteroid
|
1590 microgram
STANDARD_DEVIATION 419 • n=22 Participants
|
1477 microgram
STANDARD_DEVIATION 576 • n=86 Participants
|
1505 microgram
STANDARD_DEVIATION 548 • n=108 Participants
|
|
Number of exacerbations in the year preceding the prescription of anti IL-5
|
3.1 exacerbations
STANDARD_DEVIATION 2.5 • n=22 Participants
|
3.5 exacerbations
STANDARD_DEVIATION 0.9 • n=86 Participants
|
3.4 exacerbations
STANDARD_DEVIATION 2.1 • n=108 Participants
|
PRIMARY outcome
Timeframe: one yearPercentage of subjects achieving response to IL5/IL5R antagonists. A response to treatment was defined as a reduction of asthma exacerbations of at least 50% or a 50% or higher reduction of the OCS doses for steroid dependant patients in the year following the initiation of an IL5/IL5R antagonist compared to the year preceding the initiation of the treatment.
Outcome measures
| Measure |
Randomized Clinical Trial (RCT) In Group
n=17 Participants
Subjects who would have fulfilled the inclusion criteria of the landmark clinical trials on efficacy of IL-5/IL5R antagonists.
|
Randomized Clinical Trial (RCT) Out Group
n=80 Participants
Subjects who would have not fulfilled the inclusion criteria of the landmark clinical trials on efficacy of IL-5/IL5R antagonists.
|
|---|---|---|
|
Response to IL5/IL5R Antagonist
|
76.5 Percent
Interval 54.0 to 99.0
|
82.5 Percent
Interval 74.0 to 91.0
|
PRIMARY outcome
Timeframe: one yearPercentage of subjects achieving asthma remission. Clinical remission on treatment at one year was defined as no asthma exacerbation, no treatment with oral corticosteroid and a less than 10% decrease in pre-bronchodilator FEV1 compared with baseline value.
Outcome measures
| Measure |
Randomized Clinical Trial (RCT) In Group
n=20 Participants
Subjects who would have fulfilled the inclusion criteria of the landmark clinical trials on efficacy of IL-5/IL5R antagonists.
|
Randomized Clinical Trial (RCT) Out Group
n=78 Participants
Subjects who would have not fulfilled the inclusion criteria of the landmark clinical trials on efficacy of IL-5/IL5R antagonists.
|
|---|---|---|
|
Remission Rate With IL5/IL5R Antagonist
|
45 Percent
Interval 21.1 to 68.9
|
24.4 Percent
Interval 14.6 to 34.1
|
Adverse Events
RCT in Group
RCT Out Group
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