Trial Outcomes & Findings for The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma (NCT NCT03394508)
NCT ID: NCT03394508
Last Updated: 2020-09-28
Results Overview
0,1 ml of ALK Aquagen birch or timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded. Symptoms during NPTs were scored according to the Lebel scoring scale. Symtom scores at 5, 15, and 30 minutes after nasal administration of the allergenextract were summed to represent the symptom-score at each nasal challenge (at inclusion, 12 months after inclusion and for the active patients 24 months after inclusion). The scoring system identifies nasal, eye, and ear symptoms: rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, watery eyes, and itchy ears, each graded on a scale from 0 to 3 points, and a total score was summarized after subtracting the starting score (min score is 0 and maximum score is 54 + the number of sneezes). Higher scores mean worse outcome.
COMPLETED
PHASE2/PHASE3
30 participants
At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).
2020-09-28
Participant Flow
Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up
Participant milestones
| Measure |
Placebo
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
Intervention: Drug ALK Alutard birch or 5-grasses. Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and a booster injection with 1000 units before the second pollen season
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
17
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
Intervention: Drug ALK Alutard birch or 5-grasses. Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and a booster injection with 1000 units before the second pollen season
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=17 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and a booster injection with 1000 units before the second pollen season.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18 years
n=12 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up
|
19.5 years
n=14 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up
|
19 years
n=26 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up
|
|
Age, Customized
Age
|
18 years
n=12 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.
|
19.5 years
n=14 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.
|
19 years
n=26 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.
|
|
Sex: Female, Male
Female
|
2 Participants
n=12 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.
|
8 Participants
n=14 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.
|
10 Participants
n=26 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.
|
|
Sex: Female, Male
Male
|
10 Participants
n=12 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.
|
6 Participants
n=14 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.
|
16 Participants
n=26 Participants • Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
13 Participants
n=13 Participants
|
17 Participants
n=17 Participants
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: Patients were injected 3 times before the start of the first pollen season. The study was unblinded at a follow-up visit after the end of the first season. Active patients returned for a booster injection (1000 SQ-U) before the second season and performed a new follow-up. Eleven patients (6 active, 5 placebo) did not have full analysis data sets.
0,1 ml of ALK Aquagen birch or timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded. Symptoms during NPTs were scored according to the Lebel scoring scale. Symtom scores at 5, 15, and 30 minutes after nasal administration of the allergenextract were summed to represent the symptom-score at each nasal challenge (at inclusion, 12 months after inclusion and for the active patients 24 months after inclusion). The scoring system identifies nasal, eye, and ear symptoms: rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, watery eyes, and itchy ears, each graded on a scale from 0 to 3 points, and a total score was summarized after subtracting the starting score (min score is 0 and maximum score is 54 + the number of sneezes). Higher scores mean worse outcome.
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Change in Symptoms Score After Nasal Allergen Challenge
After the first pollen season
|
-5 score on a scale
Interval -9.0 to 5.0
|
-4 score on a scale
Interval -12.0 to 4.0
|
|
Change in Symptoms Score After Nasal Allergen Challenge
After the second season compared to pre-treatment
|
—
|
-1 score on a scale
Interval -7.0 to 2.0
|
SECONDARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: 4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.
Treatment effect was evaluated by asking the patients to compare their allergic symptoms during the last pollen season with the pollen season before treatment on a visual analogue scale ranging from 0 (unchanged symptoms, no improvement) to 10 (total symptom relief, complete recovery).
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Change on Visual Analogue Scale (VAS
After first season
|
3.5 score on a scale
Interval 0.0 to 8.5
|
5.5 score on a scale
Interval 0.0 to 9.1
|
|
Change on Visual Analogue Scale (VAS
After second season compared to pre-treatment
|
—
|
6.9 score on a scale
Interval 0.0 to 9.5
|
SECONDARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: 4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.
Difference before and after treatment in Quality of Life. Quality of life was assessed using the Juniper Asthma Quality of Life Questionnaire, giving a score ranging from 1 to 7, and a change in score of 0.5 points is considered clinically relevant. Lower value is considered worse outcome.
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Change in Quality of Life
After first season
|
0.17 units on a scale
Interval -2.0 to 2.1
|
0.3 units on a scale
Interval -0.5 to 1.1
|
|
Change in Quality of Life
After second season compared to pre-treatment
|
—
|
0.13 units on a scale
Interval -1.3 to 1.0
|
SECONDARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: 4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.
Allergen-specific IgE levels were measured by ImmunoCAP (Thermo Scientific, Uppsala, Sweden) for birch (t3) and timothy grass (g6) pollen according to the manufacturer's instructions. A cutoff level ≥ 0.35 kUA/L was considered positive.
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Change in Allergen-specific Serum Immunoglobulin E (IgE) Levels Compared to Before Treatment
IgE after first season
|
-0.5 units on a scale IgE:Kua/L
Interval -370.0 to 70.0
|
10.5 units on a scale IgE:Kua/L
Interval -50.0 to 116.0
|
|
Change in Allergen-specific Serum Immunoglobulin E (IgE) Levels Compared to Before Treatment
IgE after second season compared to pre-treatment
|
—
|
0 units on a scale IgE:Kua/L
Interval -111.0 to 83.0
|
SECONDARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: 4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.
Asthma control 4 weeks before follow-up was estimated with the asthma control test. The score is based on a questionnaire with 5 questions concerning the patients asthma. Each question can be given a score from 1 to 5 points. The answers for each question is added together, where a minimum score of 5 and a maximum score of 25 can be obtained. Higher scores indicate improved outcome and a score of 19 or less suggests poorly controlled asthma.
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Change in Asthma Symptom Scores
After the first pollen seasonllen season
|
0 score on a scale
Interval -7.0 to 4.0
|
0 score on a scale
Interval -5.0 to 3.0
|
|
Change in Asthma Symptom Scores
After second season compared to pre-treatment
|
—
|
1.5 score on a scale
Interval -10.0 to 4.0
|
SECONDARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: 4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.
FEV1 were measured according to international guidelines and results presented in % of predicted values according to the patients height, gender, age and weight.
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Change in Pulmonary Function Measurement (Spirometry)
After first season
|
-3 percent predicted FEV1
Interval -27.0 to 4.0
|
1 percent predicted FEV1
Interval -15.0 to 14.0
|
|
Change in Pulmonary Function Measurement (Spirometry)
After second season compared to pre-treatment
|
—
|
-5.5 percent predicted FEV1
Interval -32.0 to 8.0
|
SECONDARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: 4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.
Nitric oxide in exhaled air, p.p.b. were measured according to international guidelines, and higher values indicate worse outcome.
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Changes in Airway Inflammation Assessed by Exhaled Nitric Oxide
After first season
|
-5 parts per billion (ppb)
Interval -52.0 to 19.0
|
1 parts per billion (ppb)
Interval -27.0 to 13.0
|
|
Changes in Airway Inflammation Assessed by Exhaled Nitric Oxide
After second season compared to pre-treatment
|
—
|
-2.5 parts per billion (ppb)
Interval -28.0 to 28.0
|
SECONDARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: 4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.
Modified Symptom scores and Medication score were calculated taking into account the frequency: daily (4 points); every second day (3 points); 1 to 3 days per week (2 points); occasionally (1 point); never (0 points), for the following symptoms: blocked nose, rhinorrhea, fatigue, sneezing, and asthma symptoms, and for the following medications used: local and systemic antihistamines, nasal steroids, asthma medication, and eye drops. A minimum score of 0 and a maximum score of 20 points for symptoms and 16 points for medication could be obtained. Higher values indicate worse outcome.
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Change in Symptom and Medication-score
Medication score after second season
|
—
|
-3 score on a scale
Interval -12.0 to -1.0
|
|
Change in Symptom and Medication-score
Symptom score after first season
|
-3 score on a scale
Interval -7.0 to 0.0
|
-4 score on a scale
Interval -13.0 to 2.0
|
|
Change in Symptom and Medication-score
Medication score after first season
|
-2 score on a scale
Interval -4.0 to 3.0
|
-2 score on a scale
Interval -11.0 to 2.0
|
|
Change in Symptom and Medication-score
Symptom score after second season
|
—
|
-5 score on a scale
Interval -15.0 to 0.0
|
SECONDARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: 4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.
Methacholine challenge to test the bronchial hyperresponsiveness in the airways of the included subjects. The subject will inhale increasing doses of methacholine. Spirometry is performed before and between each inhalation. The cumulative dose of methacholine needed to elicit at 20% decrease in FEV1 (PD20) is reported. Lower values indicate worse outcome.
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Changes in Response to a Bronchial Challenge With Methacholine
After the first pollen season
|
-5 units on a scale PD20
Interval -150.0 to 203.0
|
23 units on a scale PD20
Interval -131.0 to 278.0
|
|
Changes in Response to a Bronchial Challenge With Methacholine
After the second pollen season compared to pre-tre
|
—
|
53 units on a scale PD20
Interval -34.0 to 489.0
|
SECONDARY outcome
Timeframe: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).Population: 4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.
Allergen-specific IgG and IgG4 level was measured by ImmunoCAP (Thermo Scientific, Uppsala, Sweden) for birch (t3) and timothy grass (g6) pollen according to the manufacturer's instructions. A cutoff 2 mg/L for IgG and 0.05 mg/L for IgG4 was considered positive.
Outcome measures
| Measure |
Placebo
n=12 Participants
ALK diluent 0,3% human albumin'
ALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
|
Active Treatment
n=14 Participants
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.
|
|---|---|---|
|
Change in Allergen-specific Serum Immunoglobulin (Ig) G and Ig4 Levels Compared to Before Treatment
IgG after first season
|
-0.25 mg/L
Interval -1.0 to 1.0
|
0.6 mg/L
Interval -1.3 to 2.9
|
|
Change in Allergen-specific Serum Immunoglobulin (Ig) G and Ig4 Levels Compared to Before Treatment
IgG4 after first season
|
0.03 mg/L
Interval -0.76 to 0.08
|
0.12 mg/L
Interval -0.73 to 2.0
|
|
Change in Allergen-specific Serum Immunoglobulin (Ig) G and Ig4 Levels Compared to Before Treatment
IgG after second season compared to pre-treatment
|
—
|
-0.2 mg/L
Interval -2.5 to 4.0
|
|
Change in Allergen-specific Serum Immunoglobulin (Ig) G and Ig4 Levels Compared to Before Treatment
IgG4 after second season compared to pre-treatment
|
—
|
0 mg/L
Interval -0.3 to 0.69
|
Adverse Events
Placebo
Active Treatment
Serious adverse events
| Measure |
Placebo
n=13 participants at risk
ALK diluent 0,3% human albumin'
ALK diluent 0.1 ml human albumin: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval
|
Active Treatment
n=17 participants at risk
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection before the second pollen season.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Generalized urticaria
|
0.00%
0/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
5.9%
1/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
5.9%
1/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Sarcoidosis
|
0.00%
0/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
5.9%
1/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
Other adverse events
| Measure |
Placebo
n=13 participants at risk
ALK diluent 0,3% human albumin'
ALK diluent 0.1 ml human albumin: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval
|
Active Treatment
n=17 participants at risk
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection before the second pollen season.
|
|---|---|---|
|
Nervous system disorders
Pain
|
7.7%
1/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
23.5%
4/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
|
Skin and subcutaneous tissue disorders
Redness
|
7.7%
1/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
47.1%
8/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
|
Skin and subcutaneous tissue disorders
Itchyness
|
0.00%
0/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
52.9%
9/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
|
Skin and subcutaneous tissue disorders
Swollen locally around injection site
|
7.7%
1/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
47.1%
8/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
7.7%
1/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
5.9%
1/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
|
Nervous system disorders
Tiredness
|
7.7%
1/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
0.00%
0/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/13 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
5.9%
1/17 • Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place