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The study evaluates the safety and efficacy of intralymphatic allergen-specific immunotherapy given to adolescents and young adults who are allergic to grass or birch pollen and have mild or moderate asthma. Patients will be treated with three intralymphatic injections; 1000 SQ-U x3 with 4-5 weeks interval, or placebo with 4-5 weeks interval. The patients receiving treatment will be given a fourth injection one year after the initial injections. The study is conducted in collaboration between Professor Lars Olof Cardell (ENT), prof Gunilla Hedlin (Pediatrics) and prof Marianne van Hage (Immunology)".
30 patients with seasonal allergic rhinitis due to birch or grass pollen are included. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses / birch or placebo. The patients receiving treatment will be given a fourth injection one year after the initial injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | ALK diluent 0,3% human albumin' |
|
| Active treatment | Experimental | Intervention: Drug ALK Alutard birch or 5-grasses. Grass pollen suspension or birch pollen suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALK Alutard birch or 5-grasses | Drug | Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval (0,1 ml) and one additional booster injection with 1000 units before the second pollen season. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptoms Score After Nasal Allergen Challenge | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change on Visual Analogue Scale (VAS | 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26706294 | Background | Patterson AM, Bonny AE, Shiels WE 2nd, Erwin EA. Three-injection intralymphatic immunotherapy in adolescents and young adults with grass pollen rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2016 Feb;116(2):168-70. doi: 10.1016/j.anai.2015.11.010. Epub 2015 Dec 17. No abstract available. | |
| 24035151 | Background |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Symptoms Score After Nasal Allergen Challenge | 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 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). |
Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Generalized urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Systematic Assessment |
a=active,p=placebo:No booster dose and no follow-up (1a), No NPTs before (1a) and at follow up (1a, 1p), No methacholine, quality of life in the second follow-up (1a). No symptoms and medication scores (3a, 3p), No spirometry at follow-up (1a,1p).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon Konradsen | Karolinska Institutet | +46704242058 | jon.konradsen@ki.se |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2019 | Feb 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| ALK diluent 0,3% human albumin | Drug | Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval |
|
|
| Change in Quality of Life | 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. | 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). |
| Change in Allergen-specific Serum Immunoglobulin E (IgE) Levels Compared to Before Treatment | 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. | 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). |
| Change in Asthma Symptom Scores | 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. | 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). |
| Change in Pulmonary Function Measurement (Spirometry) | FEV1 were measured according to international guidelines and results presented in % of predicted values according to the patients height, gender, age and weight. | 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). |
| Changes in Airway Inflammation Assessed by Exhaled Nitric Oxide | Nitric oxide in exhaled air, p.p.b. were measured according to international guidelines, and higher values indicate worse outcome. | 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). |
| Change in Symptom and Medication-score | 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. | 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). |
| Changes in Response to a Bronchial Challenge With Methacholine | 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. | 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). |
| Change in Allergen-specific Serum Immunoglobulin (Ig) G and Ig4 Levels Compared to Before Treatment | 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. | 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). |
| Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013 Nov;132(5):1248-1252.e5. doi: 10.1016/j.jaci.2013.07.033. Epub 2013 Sep 13. No abstract available. |
| 23374268 | Background | Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056. |
| 22464647 | Background | Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30. |
| 26817454 | Result | Hylander T, Larsson O, Petersson-Westin U, Eriksson M, Kumlien Georen S, Winqvist O, Cardell LO. Intralymphatic immunotherapy of pollen-induced rhinoconjunctivitis: a double-blind placebo-controlled trial. Respir Res. 2016 Jan 27;17:10. doi: 10.1186/s12931-016-0324-9. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Full Range |
| years |
|
| Age, Customized | 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. | Median | Full Range | years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Change on Visual Analogue Scale (VAS | 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). | 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. | Posted | Median | Full Range | score on a scale | 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). |
|
|
|
| Secondary | Change in Quality of Life | 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. | 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. | Posted | Median | Full Range | units on a scale | 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). |
|
|
|
| Secondary | Change in Allergen-specific Serum Immunoglobulin E (IgE) Levels Compared to Before Treatment | 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. | 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. | Posted | Median | Full Range | units on a scale IgE:Kua/L | 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). |
|
|
|
| Secondary | Change in Asthma Symptom Scores | 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. | 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. | Posted | Median | Full Range | score on a scale | 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). |
|
|
|
| Secondary | Change in Pulmonary Function Measurement (Spirometry) | FEV1 were measured according to international guidelines and results presented in % of predicted values according to the patients height, gender, age and weight. | 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. | Posted | Median | Full Range | percent predicted FEV1 | 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). |
|
|
|
| Secondary | Changes in Airway Inflammation Assessed by Exhaled Nitric Oxide | Nitric oxide in exhaled air, p.p.b. were measured according to international guidelines, and higher values indicate worse outcome. | 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. | Posted | Median | Full Range | parts per billion (ppb) | 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). |
|
|
|
| Secondary | Change in Symptom and Medication-score | 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. | 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. | Posted | Median | Full Range | score on a scale | 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). |
|
|
|
| Secondary | Changes in Response to a Bronchial Challenge With Methacholine | 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale PD20 | 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). |
|
|
|
| Secondary | Change in Allergen-specific Serum Immunoglobulin (Ig) G and Ig4 Levels Compared to Before Treatment | 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. | 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. | Posted | Median | Full Range | mg/L | 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). |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 5 |
| 13 |
| EG001 | 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 an additional booster injection before the second pollen season. | 0 | 17 | 2 | 17 | 13 | 17 |
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sarcoidosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | One patient was diagnosed with Sarcoidosis 3 months after the booster injection. |
|
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itchyness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swollen locally around injection site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tiredness | Nervous system disorders | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment | The patient reported worsened eczema after the first treatment period and declined the booster dose |
|
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| D010038 |
| Otorhinolaryngologic Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| After second season compared to pre-treatment |
|
|
| After second season compared to pre-treatment |
|
|
| IgE after second season compared to pre-treatment |
|
|
| After second season compared to pre-treatment |
|
|
| After second season compared to pre-treatment |
|
|
| After second season compared to pre-treatment |
|
|
| Medication score after first season |
|
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| Symptom score after second season |
|
|
| Medication score after second season |
|
|
| After the second pollen season compared to pre-tre |
|
|
| IgG4 after first season |
|
|
| IgG after second season compared to pre-treatment |
|
|
| IgG4 after second season compared to pre-treatment |
|
|