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The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.
Double blind placebo controlled study to assess the expression of IgE on blood basophils and dendritic cells in patients with uncontrolled, severe, persistent allergic asthma after a 16-week Omalizumab treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Active Comparator | Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level. |
|
| Placebo | Placebo Comparator | Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | Omalizumab was supplied as a sterile, freeze dried preparation, to be reconstituted to deliver 150mg of omalizumab. Each vial was reconstituted with 1.4ml of sterile water for injection. The appropriate dose and dosing frequency of omalizumab were determined by baseline total IgE and body weight. A dosing table was used following the European Summary of Product Characteristics (SmPC) of omalizumab. |
| Measure | Description | Time Frame |
|---|---|---|
| Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo | Blood was drawn from participants at baseline and at Week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value. | Baseline and Week 16 |
| Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo | Blood was drawn from participants at baseline and at week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value. | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment | Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator site | Rueil-Malmaison | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20801010 | Derived | Chanez P, Contin-Bordes C, Garcia G, Verkindre C, Didier A, De Blay F, de Lara MT, Blanco P, Moreau JF, Robinson P, Bourdeix I, Trunet P, Le Gros V, Humbert M, Molimard M. Omalizumab-induced decrease of FcxiRI expression in patients with severe allergic asthma. Respir Med. 2010 Nov;104(11):1608-17. doi: 10.1016/j.rmed.2010.07.011. Epub 2010 Aug 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab | Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level. |
| FG001 | Placebo | Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab | Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo | Blood was drawn from participants at baseline and at Week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value. | The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment. | Posted | Mean | Standard Deviation | percent change in FcεRI expression | Baseline and Week 16 |
|
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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 | Omalizumab | Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| placebo | Drug | Placebo was a physiological salt solution, administered according to the same administration scheme to respect the same dosing frequency and injected volume. |
|
| Baseline, Weeks 4, 8, 12 and 16 |
| Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment | Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value. | Baseline, Weeks 4, 8, 12, and 16 |
| Change From Baseline in the Number of Days With Asthma Symptoms Per Week | Participants maintained a diary to record the number of days with daytime asthma symptoms per week. This analysis compares the mean number of days per week with asthma symptoms during the 4-week screening period prior to randomization with the mean number of days per wek with asthma symptoms in the last 4 weeks of study treatment (Weeks 12 -16). | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
| Change From Baseline in the Number of Puffs of Rescue Medication Per Week | Participants maintained a diary to record the daytime number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms per week. This analysis compares the mean number of puffs of rescue medication per week during the 4 week screening period prior to randomization to the mean number of puffs per week during the last 4 weeks on study treatment (Weeks 12 - 16). | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
| Change From Baseline in the Number of Nights With Awakenings Per Week | Participants maintained a diary to record the number of nights with awakenings due to asthma symptoms per week. For this analysis, the mean number of nights with awakenings per week during the 4 week screening period prior to randomization was compared with the mean number of nights with awakenings per week during the last 4 weeks of study treatment (Weeks 12 - 16). | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
| Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week | Impairment was defined as days with physical activity considered as limited (or "not normal") according to patient's assessment and was recorded in a patient daily diary. For this analysis, the mean number of days with impairment per week during the 4 week screening period prior to randomization was compared with the mean number of days with impairment per week during the last 4 weeks on study treatment (Weeks 12 - 16). | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
| Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms | Participants maintained a diary to record the number of days with absence from school or work due to asthma symptoms. For this analysis, the number of days with absence from school or work in the four weeks prior to randomization (screening period) were compared with the number of absence days during the last 4 weeks on study treatment (Weeks 12 - 16). | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
| Change From Baseline in the Number of Days With Hospitalizations | Participants maintained a diary to record the number of days with hospitalizations during the study. For this analysis, the number of days with hospitalizations during the screening period (4 weeks prior to randomization) was compared with the number of days with hospitalizations during the last 4 weeks on study treatment (Weeks 12 - 16). | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
| Change From Baseline in the Number of Unscheduled Clinic Visits | Participants maintained a diary to record the number of unscheduled clinic visits during the study. For this analysis, the number of unscheduled visits during the 4 week screening period prior to randomization is compared with the number of unscheduled visits during the last 4 weeks on treatment (Weeks 12 - 16). | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
| Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF) | Peak Expiratory Flow (PEF) was measured every morning using a peak flow meter, and was recorded in the patient diary. For this analysis, the mean morning PEF during the 4-week screening period prior to randomizaton is compared with the mean morning PEF during the last 4 weeks of study treatment (Weeks 12 - 16). | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
| Physician's Overall Assessment of Treatment Effectiveness | The Physician's overall assessment of treatment effectiveness was graded 1-5 as 1 = Excellent asthma control (complete control) 2 = Good asthma control (marked improvement) 3 = Moderate asthma control (discernible, but limited improvement) 4 = Poor asthma control (no appreciable change) 5 = Very poor asthma control (worsening) | After 16 weeks of treatment |
| Protocol Violation |
|
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Omalizumab |
Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level. |
| OG001 | Placebo | Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. |
|
|
| Secondary | Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment | Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value. | A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points. | Posted | Mean | Standard Deviation | percent change in cells expressing FcεRI | Baseline, Weeks 4, 8, 12 and 16 |
|
|
|
| Secondary | Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment | Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value. | A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points. | Posted | Mean | Standard Deviation | % change in fluorescence intensity | Baseline, Weeks 4, 8, 12, and 16 |
|
|
|
| Secondary | Change From Baseline in the Number of Days With Asthma Symptoms Per Week | Participants maintained a diary to record the number of days with daytime asthma symptoms per week. This analysis compares the mean number of days per week with asthma symptoms during the 4-week screening period prior to randomization with the mean number of days per wek with asthma symptoms in the last 4 weeks of study treatment (Weeks 12 -16). | The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. | Posted | Mean | Standard Deviation | days per week | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
|
|
|
| Primary | Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo | Blood was drawn from participants at baseline and at week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value. | The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment. | Posted | Mean | Standard Deviation | percent change in fluorescence intensity | Baseline and Week 16 |
|
|
|
| Secondary | Change From Baseline in the Number of Puffs of Rescue Medication Per Week | Participants maintained a diary to record the daytime number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms per week. This analysis compares the mean number of puffs of rescue medication per week during the 4 week screening period prior to randomization to the mean number of puffs per week during the last 4 weeks on study treatment (Weeks 12 - 16). | The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. | Posted | Mean | Standard Deviation | puffs per week | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
|
|
|
| Secondary | Change From Baseline in the Number of Nights With Awakenings Per Week | Participants maintained a diary to record the number of nights with awakenings due to asthma symptoms per week. For this analysis, the mean number of nights with awakenings per week during the 4 week screening period prior to randomization was compared with the mean number of nights with awakenings per week during the last 4 weeks of study treatment (Weeks 12 - 16). | The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. | Posted | Mean | Standard Deviation | nights with awakenings per week | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
|
|
|
| Secondary | Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week | Impairment was defined as days with physical activity considered as limited (or "not normal") according to patient's assessment and was recorded in a patient daily diary. For this analysis, the mean number of days with impairment per week during the 4 week screening period prior to randomization was compared with the mean number of days with impairment per week during the last 4 weeks on study treatment (Weeks 12 - 16). | The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. | Posted | Mean | Standard Deviation | days per week | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
|
|
|
| Secondary | Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms | Participants maintained a diary to record the number of days with absence from school or work due to asthma symptoms. For this analysis, the number of days with absence from school or work in the four weeks prior to randomization (screening period) were compared with the number of absence days during the last 4 weeks on study treatment (Weeks 12 - 16). | The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. | Posted | Mean | Standard Deviation | days | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
|
|
|
| Secondary | Change From Baseline in the Number of Days With Hospitalizations | Participants maintained a diary to record the number of days with hospitalizations during the study. For this analysis, the number of days with hospitalizations during the screening period (4 weeks prior to randomization) was compared with the number of days with hospitalizations during the last 4 weeks on study treatment (Weeks 12 - 16). | The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. | Posted | Mean | Standard Deviation | days | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
|
|
|
| Secondary | Change From Baseline in the Number of Unscheduled Clinic Visits | Participants maintained a diary to record the number of unscheduled clinic visits during the study. For this analysis, the number of unscheduled visits during the 4 week screening period prior to randomization is compared with the number of unscheduled visits during the last 4 weeks on treatment (Weeks 12 - 16). | The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. | Posted | Mean | Standard Deviation | unscheduled visits | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
|
|
|
| Secondary | Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF) | Peak Expiratory Flow (PEF) was measured every morning using a peak flow meter, and was recorded in the patient diary. For this analysis, the mean morning PEF during the 4-week screening period prior to randomizaton is compared with the mean morning PEF during the last 4 weeks of study treatment (Weeks 12 - 16). | The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. | Posted | Mean | Standard Deviation | liters per minute | Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) |
|
|
|
| Secondary | Physician's Overall Assessment of Treatment Effectiveness | The Physician's overall assessment of treatment effectiveness was graded 1-5 as 1 = Excellent asthma control (complete control) 2 = Good asthma control (marked improvement) 3 = Moderate asthma control (discernible, but limited improvement) 4 = Poor asthma control (no appreciable change) 5 = Very poor asthma control (worsening) | The ITT population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. Complete data for 26 of the total 30 participants was recorded. | Posted | Number | participants | After 16 weeks of treatment |
|
|
|
| 0 |
| 20 |
| 13 |
| 20 |
| EG001 | Placebo | Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. | 1 | 11 | 7 | 11 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| % change Basophils expressing FcεRI at Week 12 |
|
| % change Basophils expressing FcεRI at Week 16 |
|
| % change Dendritic cells expressing FcεRI Week 4 |
|
| % change Dendritic cells expressing FcεRI Week 8 |
|
| % change Dendritic cells expressing FcεRI Week 12 |
|
| % change Dendritic cells expressing FcεRI Week 16 |
|
| % change on basophils at Week 12 |
|
| % change on basophils at Week 16 |
|
| % change on dendritic cells at Week 4 |
|
| % change on dendritic cells at Week 8 |
|
| % change on dendritic cells at Week 12 |
|
| % change on dendritic cells at Week 16 |
|
| Moderate |
|
| Poor |
|
| Worsening |
|