Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.
This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in seasonal asthma.
This study was a follow-up to the core IGE025ADE03 study, in which patients received omalizumab treatment. In this follow-up study, no patient received omalizumab.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depigold+Omalizumab | Experimental | Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50) |
|
| Depigoid+Placebo | Experimental | Depigoid® (grass/rye pollen 50/50) + Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depigoid | Drug | Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Symptom Load | The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site. | Recorded daily during the 2007 and 2008 pollen season |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma/Rhinoconjunctivitis Symptom Severity Score | The symptom severity score was defined as the mean of the daily symptom severity scores (asthma symptoms during the day, asthma symptoms at night, rhinitis symptoms, and conjunctivitis symptoms) during the pollen season. The daily symptom severity scores were evaluated daily by the patient using a 4-point scale (0 = none (no symptom), 1 = mild, 2 = moderate, 3 = severe) and were recorded in a patient diary. The possible minimum value for the Asthma/Rhinoconjunctivitis Symptom Severity Score is 0, and the possible maximum value is 3. Higher values represent a worse outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Females of childbearing potential: pregnancy, birth control,breast-feeding
Concurrent diseases/conditions and history of other diseases/conditions
Ingredient hypersensitivity
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals, Basel +41 61 324 1111. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator site | Nuremberg | Germany |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Depigoid + Omalizumab | Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study. |
| FG001 | Depigoid + Placebo | Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - 2007 |
|
| |||||||||||||||||||||
| Between Period 1 and Period 2 |
| ||||||||||||||||||||||
| Period 2 - 2008 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Depigoid + Omalizumab | Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study. |
| BG001 | Depigoid + 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 | Daily Symptom Load | The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site. | Intent-to-Treat (ITT). The complete analysis population who consisted of all patients that received at least one dose of study drug was used for all efficacy and safety evaluations in this extension period. | Posted | Mean | Standard Deviation | units on a scale | Recorded daily during the 2007 and 2008 pollen season |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Depigoid + Omalizumab 2007 | Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA | Systematic Assessment |
Study Start Date: February 2006 (core study)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
Not provided
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Omalizumab | Drug | anti-IgE (Omalizumab) given during the 2006 core study |
|
|
| Placebo | Drug | Placebo given during the 2006 core study |
|
| Recorded daily during the 2007 and 2008 pollen season |
| Asthma/Rhinoconjunctivitis Rescue Medication Score | Asthma/Rhinoconjunctivitis rescue medication score is a component of symptom load. Patients were advised that between visits they could take short acting β-2 agonist rescue medication as initial rescue medication for symptoms of intercurrent bronchospasm. Patients were advised that between visits they could take rescue medication (systemic antihistamines) on an as-needed basis for symptoms of grass pollen allergic rhinoconjunctivitis. The symptom load and all its components were based on the patient's entries in their diaries. | Recorded daily during the 2007 and 2008 pollen season |
| Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator | The investigator's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing'). | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
| Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient | The patient's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing'). | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
| Asthma Control Questionnaire (ACQ) | The Asthma Control Questionnaire (ACQ) was developed and validated for assessing asthma symptom control in patients in clinical trials as well as for individuals in clinical practice. It is a simple questionnaire consisting of seven questions assessing symptoms, airway caliber and rescue β2-agonist use. It uses a 7-point scale. The possible minimum value is 1, the possible maximum value is 7. Higher values represent worse asthma control and quality of life, respectively. | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
| Asthma Quality of Life Questionnaire (AQLQ) | The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains (symptoms, emotions, exposure to environmental stimuli and activity limitation). Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions (low=1, high=7). Higher values represent better quality of life. | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinoconjunctivitis. It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions). Patients recall their experiences during the previous week and to score each item on a 7-point scale. The overall RQLQ score is the mean response to all 28 questions (low=1, high=7). Higher values represent worse quality of life. | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
| Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline | Both the AQLQ and RQLQ clinical differences were categorized as important, moderate, or meaningful improvement; no clinical change; meaningful, moderate, or important impairment. Clinically important differences in scores between any two assessments have been determined by the authors of the AQLQ and RQLQ. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score. | Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
| Work Productivity and Activity Impairment | The Work Productivity and Activity Impairment questionnaire measures time missed from work, impairment of work and regular activities. It consists of 6 items. The outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. The minimum value is 0 (0 %), the maximum value is 1 (100%). The recall time is 1 week. For this study WPAI-AA was used defining the specific health problem as allergic asthma, which has been validated by the instrument owner. | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
| Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1) | The spirometric parameter Forced Expiratory Volume in One Second (FEV1) was measured during grass pollen season before each injection of Depigoid. | Assist during 2007 and 2008 pollen season |
| Lung Function as Assessed by Peak Expiratory Flow (PEF) | The spirometric parameter Peak Expiratory Flow (PEF) was measured during grass pollen season before each injection of Depigoid. PEF was collected in the patient diary at seven days after visit 22, 23 and 24 as well as 35, 36 and 37. For analyzing purposes these data were averaged after the respective visits. Missing PEF-values from the patient diary were not replaced. | Assist during 2007 and 2008 pollen season |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | 2007 Open Label (OL) extension phase | Number | participants |
|
| Age, Customized | 2008 Open Label (OL) extension phase(N count for Depigoid+Omalizumab is 59 and for Depigoid+Placebo is 55) | Number | participants |
|
| Sex/Gender, Customized | 2007 Open Label (OL) extension phase | Number | participants |
|
| Sex/Gender, Customized | 2008 Open Label (OL) extension phase(N count for Depigoid+Omalizumab is 59 and for Depigoid+Placebo is 55) | Number | participants |
|
| Race/Ethnicity, Customized | 2008 Open Label (OL) extension phase (N count for Depigoid+Omalizumab is 59 and for Depigoid+Placebo is 55) | Number | participants |
|
| Race/Ethnicity, Customized | 2007 Open Label (OL) extension phase | Number | participants |
|
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study. |
| OG001 | Depigoid + Placebo | Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study |
|
|
| Secondary | Asthma/Rhinoconjunctivitis Symptom Severity Score | The symptom severity score was defined as the mean of the daily symptom severity scores (asthma symptoms during the day, asthma symptoms at night, rhinitis symptoms, and conjunctivitis symptoms) during the pollen season. The daily symptom severity scores were evaluated daily by the patient using a 4-point scale (0 = none (no symptom), 1 = mild, 2 = moderate, 3 = severe) and were recorded in a patient diary. The possible minimum value for the Asthma/Rhinoconjunctivitis Symptom Severity Score is 0, and the possible maximum value is 3. Higher values represent a worse outcome. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | Recorded daily during the 2007 and 2008 pollen season |
|
|
|
| Secondary | Asthma/Rhinoconjunctivitis Rescue Medication Score | Asthma/Rhinoconjunctivitis rescue medication score is a component of symptom load. Patients were advised that between visits they could take short acting β-2 agonist rescue medication as initial rescue medication for symptoms of intercurrent bronchospasm. Patients were advised that between visits they could take rescue medication (systemic antihistamines) on an as-needed basis for symptoms of grass pollen allergic rhinoconjunctivitis. The symptom load and all its components were based on the patient's entries in their diaries. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | Recorded daily during the 2007 and 2008 pollen season |
|
|
|
| Secondary | Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator | The investigator's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing'). | Intent-to-Treat (ITT) | Posted | Number | percentage of participants | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
|
|
|
| Secondary | Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient | The patient's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing'). | Intent-to-Treat (ITT) | Posted | Number | percentage of participants | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
|
|
|
| Secondary | Asthma Control Questionnaire (ACQ) | The Asthma Control Questionnaire (ACQ) was developed and validated for assessing asthma symptom control in patients in clinical trials as well as for individuals in clinical practice. It is a simple questionnaire consisting of seven questions assessing symptoms, airway caliber and rescue β2-agonist use. It uses a 7-point scale. The possible minimum value is 1, the possible maximum value is 7. Higher values represent worse asthma control and quality of life, respectively. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
|
|
|
| Secondary | Asthma Quality of Life Questionnaire (AQLQ) | The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains (symptoms, emotions, exposure to environmental stimuli and activity limitation). Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions (low=1, high=7). Higher values represent better quality of life. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
|
|
|
| Secondary | Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinoconjunctivitis. It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions). Patients recall their experiences during the previous week and to score each item on a 7-point scale. The overall RQLQ score is the mean response to all 28 questions (low=1, high=7). Higher values represent worse quality of life. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
|
|
|
| Secondary | Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline | Both the AQLQ and RQLQ clinical differences were categorized as important, moderate, or meaningful improvement; no clinical change; meaningful, moderate, or important impairment. Clinically important differences in scores between any two assessments have been determined by the authors of the AQLQ and RQLQ. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score. | Intent-to-Treat (ITT) | Posted | Number | participants | Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
|
|
|
| Secondary | Work Productivity and Activity Impairment | The Work Productivity and Activity Impairment questionnaire measures time missed from work, impairment of work and regular activities. It consists of 6 items. The outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. The minimum value is 0 (0 %), the maximum value is 1 (100%). The recall time is 1 week. For this study WPAI-AA was used defining the specific health problem as allergic asthma, which has been validated by the instrument owner. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 52 Weeks (2007) and 104 Weeks (2008) after completion of core study |
|
|
|
| Secondary | Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1) | The spirometric parameter Forced Expiratory Volume in One Second (FEV1) was measured during grass pollen season before each injection of Depigoid. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | milliliters (mL) | Assist during 2007 and 2008 pollen season |
|
|
|
| Secondary | Lung Function as Assessed by Peak Expiratory Flow (PEF) | The spirometric parameter Peak Expiratory Flow (PEF) was measured during grass pollen season before each injection of Depigoid. PEF was collected in the patient diary at seven days after visit 22, 23 and 24 as well as 35, 36 and 37. For analyzing purposes these data were averaged after the respective visits. Missing PEF-values from the patient diary were not replaced. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | liters per minute (L/min) | Assist during 2007 and 2008 pollen season |
|
|
|
| 2 |
| 65 |
| 36 |
| 65 |
| EG001 | Depigoid + Omalizumab 2008 | Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study. | 5 | 59 | 32 | 59 |
| EG002 | Depigoid + Placebo 2007 | Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study | 2 | 63 | 34 | 63 |
| EG003 | Depigoid + Placebo 2008 | Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study | 1 | 55 | 26 | 55 |
| Tachyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | 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 |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal 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.
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 2007:3 = Moderate |
|
| 2007:4 = Poor |
|
| 2007:5 = Worsening |
|
| 2007:(.) = Missing |
|
| 2007:Responders (1+2) |
|
| 2008: 1 = Excellent |
|
| 2008:2 = Good |
|
| 2008:3 = Moderate |
|
| 2008:4 = Poor |
|
| 2008:5 = Worsening |
|
| 2008:(.) = Missing |
|
| 2008:Responders (1+2) |
|
| 2007: 3 = Moderate |
|
| 2007: 4 = Poor |
|
| 2007: 5 = Worsening |
|
| 2007: (.) = Missing |
|
| 2008: 1 = Excellent |
|
| 2008: 2 = Good |
|
| 2008: 3 = Moderate |
|
| 2008: 4 = Poor |
|
| 2008: 5 = Worsening |
|
| 2008: (.) = Missing |
|
| 2007 AQLQ: meaningful improvement |
|
| 2007 AQLQ: no clinical change |
|
| 2007 AQLQ: meaningful impairment |
|
| 2007 AQLQ: moderate impairment |
|
| 2007 AQLQ: important impairment |
|
| 2007 AQLQ: missing |
|
| 2007 RQLQ: important improvement |
|
| 2007 RQLQ: moderate improvement |
|
| 2007 RQLQ: meaningful improvement |
|
| 2007 RQLQ: no clinical change |
|
| 2007 RQLQ: meaningful impairment |
|
| 2007 RQLQ: moderate impairment |
|
| 2007 RQLQ: important impairment |
|
| 2007 RQLQ: missing |
|
| 2008 AQLQ: important improvement |
|
| 2008 AQLQ: moderate improvement |
|
| 2008 AQLQ: meaningful improvement |
|
| 2008 AQLQ: no clinical change |
|
| 2008 AQLQ: meaningful impairment |
|
| 2008 AQLQ: moderate impairment |
|
| 2008 AQLQ: important impairment |
|
| 2008 AQLQ: missing |
|
| 2008 RQLQ: important improvement |
|
| 2008 RQLQ: moderate improvement |
|
| 2008 RQLQ: meaningful improvement |
|
| 2008 RQLQ: no clinical change |
|
| 2008 RQLQ: meaningful impairment |
|
| 2008 RQLQ: moderate impairment |
|
| 2008 RQLQ: important impairment |
|
| 2008 RQLQ: missing |
|
| 2007: Overall work impairment due to asthma |
|
| 2007: Activitiy impairment due to asthma |
|
| 2007Time in school activities missed due to asthma |
|
| 2007:Impairment in school activities due to asthma |
|
| 2007: Overall impairment/activities due to asthma |
|
| 2008: Work time missed due to asthma |
|
| 2008: Impairment while working due to asthma |
|
| 2008: Overall work impairment due to asthma |
|
| 2008: Activitiy impairment due to asthma |
|
| 2008Time in school activities missed due to asthma |
|
| 2008:Impairment in school activities due to asthma |
|
| 2008: Overall impairment/activities due to asthma |
|