Trial Outcomes & Findings for Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab) (NCT NCT04823585)
NCT ID: NCT04823585
Last Updated: 2026-03-24
Results Overview
SNOT-22 is a validated symptom questionnaire. The score ranges between 0 and 110. A higher score means worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
95 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2026-03-24
Participant Flow
Participant milestones
| Measure |
Subcutaneous Injections of Mepolizumab 100 mg
Subcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections.
|
Subcutaneous Injections of Placebo
Subcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)
Baseline characteristics by cohort
| Measure |
Subcutaneous Injections of Placebo
n=47 Participants
Subcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections.
Placebo: Solution. Subcutaneous.
|
Subcutaneous Injections of Mepolizumab 100 mg
n=47 Participants
Subcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections.
Mepolizumab: Solution. Subcutaneous. Mepolizumab is a biological drug, a humanized monoclonal antibody against interleukin-5.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 12.8 • n=138 Participants
|
53 years
STANDARD_DEVIATION 13.5 • n=62 Participants
|
52.8 years
STANDARD_DEVIATION 13.2 • n=123 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=138 Participants
|
27 Participants
n=62 Participants
|
51 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=138 Participants
|
20 Participants
n=62 Participants
|
43 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
46 Participants
n=138 Participants
|
47 Participants
n=62 Participants
|
93 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Region of Enrollment
Finland
|
47 participants
n=138 Participants
|
47 participants
n=62 Participants
|
94 participants
n=123 Participants
|
|
SNOT-22 Total score
|
41.9 points
STANDARD_DEVIATION 14.3 • n=138 Participants
|
45.1 points
STANDARD_DEVIATION 18.3 • n=62 Participants
|
43.5 points
STANDARD_DEVIATION 16.5 • n=123 Participants
|
|
Nasal polyp score
|
5.6 points
STANDARD_DEVIATION 1.3 • n=138 Participants
|
5.5 points
STANDARD_DEVIATION 1.2 • n=62 Participants
|
5.6 points
STANDARD_DEVIATION 1.3 • n=123 Participants
|
|
Asthma Control Test Total points
|
20.4 points
STANDARD_DEVIATION 3.5 • n=138 Participants
|
19.9 points
STANDARD_DEVIATION 5.1 • n=62 Participants
|
20.2 points
STANDARD_DEVIATION 4.4 • n=123 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16SNOT-22 is a validated symptom questionnaire. The score ranges between 0 and 110. A higher score means worse outcome.
Outcome measures
| Measure |
Subcutaneous Injections of Mepolizumab 100 mg
n=32 Participants
Subcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections.
|
Subcutaneous Injections of Placebo
n=35 Participants
Subcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections.
|
|---|---|---|
|
Change From Baseline at Week 16 in Sinonasal Outcome Test -22 (SNOT-22) Score
|
-14.09 points
Standard Error 2.01
|
-4.37 points
Standard Error 2.26
|
PRIMARY outcome
Timeframe: Baseline, Week 16The nasal polyp score (NPS) is assessed bilaterally. Each nasal cavity is graded separately according to polyp size on a scale from 0 (no polyps) to 4 (large polyps causing complete obstruction of the inferior nasal cavity). The total nasal polyp score ranges from 0 to 8 points.
Outcome measures
| Measure |
Subcutaneous Injections of Mepolizumab 100 mg
n=45 Participants
Subcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections.
|
Subcutaneous Injections of Placebo
n=46 Participants
Subcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections.
|
|---|---|---|
|
Change From Baseline at Week 16 in Endoscopic Nasal Polyp Score of Nasal Cavity
|
-1.482 points
Standard Error 0.216
|
-0.675 points
Standard Error 0.214
|
SECONDARY outcome
Timeframe: Baseline, Week 16The Asthma Control Test (ACT) is a validated, patient-reported questionnaire used to assess asthma control. Minimum score: 5 points. Maximum score: 25 points. 20-25 points: Well-controlled asthma. ≤15 points: Poorly controlled asthma.
Outcome measures
| Measure |
Subcutaneous Injections of Mepolizumab 100 mg
n=42 Participants
Subcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections.
|
Subcutaneous Injections of Placebo
n=36 Participants
Subcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections.
|
|---|---|---|
|
Change From Baseline at Week 16 in Asthma Control Test Score
|
2.228 points
Standard Error 0.518
|
0.025 points
Standard Error 0.548
|
SECONDARY outcome
Timeframe: at 16 weeksPercentage of observed Forced expiratory volume in 1 second (FEV1) of predicted FEV1
Outcome measures
| Measure |
Subcutaneous Injections of Mepolizumab 100 mg
n=46 Participants
Subcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections.
|
Subcutaneous Injections of Placebo
n=46 Participants
Subcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections.
|
|---|---|---|
|
Change in FEV1%
|
2.33 percent
Standard Error 1.88
|
1.61 percent
Standard Error 1.90
|
Adverse Events
Subcutaneous Injections of Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Subcutaneous Injections of Mepolizumab 100 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subcutaneous Injections of Placebo
n=48 participants at risk
Subcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections.
|
Subcutaneous Injections of Mepolizumab 100 mg
n=47 participants at risk
Subcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections.
|
|---|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/48 • from enrollment until end of follow-up, up to 20 weeks
|
2.1%
1/47 • from enrollment until end of follow-up, up to 20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia (hospitalization)
|
0.00%
0/48 • from enrollment until end of follow-up, up to 20 weeks
|
2.1%
1/47 • from enrollment until end of follow-up, up to 20 weeks
|
Other adverse events
| Measure |
Subcutaneous Injections of Placebo
n=48 participants at risk
Subcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections.
|
Subcutaneous Injections of Mepolizumab 100 mg
n=47 participants at risk
Subcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea, headache, dizzines
|
8.3%
4/48 • from enrollment until end of follow-up, up to 20 weeks
|
2.1%
1/47 • from enrollment until end of follow-up, up to 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/48 • from enrollment until end of follow-up, up to 20 weeks
|
4.3%
2/47 • from enrollment until end of follow-up, up to 20 weeks
|
|
Eye disorders
Ocular symptom
|
4.2%
2/48 • from enrollment until end of follow-up, up to 20 weeks
|
0.00%
0/47 • from enrollment until end of follow-up, up to 20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract symptom
|
2.1%
1/48 • from enrollment until end of follow-up, up to 20 weeks
|
0.00%
0/47 • from enrollment until end of follow-up, up to 20 weeks
|
|
Skin and subcutaneous tissue disorders
Skin-related symptom
|
4.2%
2/48 • from enrollment until end of follow-up, up to 20 weeks
|
2.1%
1/47 • from enrollment until end of follow-up, up to 20 weeks
|
|
Gastrointestinal disorders
Tongue pain
|
0.00%
0/48 • from enrollment until end of follow-up, up to 20 weeks
|
2.1%
1/47 • from enrollment until end of follow-up, up to 20 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place