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A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.
This study was designed to provide one year efficacy and safety data for subcutaneous (SC) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to National Heart, Lung and Blood Institute (NHLBI) step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Experimental | Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
|
| Placebo | Placebo Comparator | Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period | A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period. | Baseline to end of the fixed-dose steroid treatment period (Week 24) |
| Percentage of Participants With at Least 1 Adverse Event | See Adverse Events module for details. | Baseline to end of the study (Week 68) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question "How did you sleep last night?", with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Allergy and Asthma Center | Birmingham | Alabama | 35209 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39309477 | Derived | Fiocchi A, Chinthrajah RS, Ansotegui IJ, Sriaroon P, Mustafa SS, Raut P, Cameron B, Gupta S, Fleischer DM. Does Comorbid Food Allergy Affect Response to Omalizumab in Patients with Asthma? J Asthma Allergy. 2024 Sep 17;17:889-900. doi: 10.2147/JAA.S475517. eCollection 2024. | |
| 37088376 | Derived | Witonsky J, Elhawary JR, Millette LA, Holweg CTJ, Ko J, Raut P, Borrell LN. Similar response to omalizumab in children with allergic asthma from different racial backgrounds. J Allergy Clin Immunol Pract. 2023 Sep;11(9):2911-2913. doi: 10.1016/j.jaip.2023.03.055. Epub 2023 Apr 23. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab | Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol. |
|
| Fluticasone | Drug | Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler. |
|
| Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period |
| Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period | A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period. | Baseline to end of the treatment period (Week 52) |
| Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication. | Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period |
| Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24) | PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates. | Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24) |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Clinical Research Center | Little Rock | Arkansas | 72205 | United States |
| Allergy and Asthma Specialists Medical Group | Huntington Beach | California | 92647 | United States |
| Pediatric Care and Medical Group | Huntington Beach | California | 92647 | United States |
| West Coast Clinical Trials | Long Beach | California | 90806 | United States |
| Southern California Research Center | Mission Viejo | California | 92691 | United States |
| Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology | Orange | California | 92868 | United States |
| CA Allergy & Asthma Med Group | Palmdale | California | 93551 | United States |
| Dr. Joann Blessing-Moore | Palo Alto | California | 94304 | United States |
| Integrated Research Group | Riverside | California | 92506 | United States |
| Allergy Associates Medical Group | San Diego | California | 92120 | United States |
| Allergy and Asthma Medical Group & Research Center | San Diego | California | 92123 | United States |
| Allergy and Asthma Associates of Santa Clara Valley RC | San Jose | California | 95117 | United States |
| 1304 15th St | Santa Monica | California | 90404 | United States |
| Bensch Research Associates | Stockton | California | 95207 | United States |
| Allergy & Asthma Med Group of Diablo Valley CR | Walnut Creek | California | 94598 | United States |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| Georgia Pollens | Albany | Georgia | 31707 | United States |
| Family Allergy and Asthma Center, PC | Atlanta | Georgia | 30342 | United States |
| Aeroallergy Research Labs of Savannah, Inc | Savannah | Georgia | 31406 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Asthma & Allergy Center | Elliott | Maryland | 21042 | United States |
| Northeast Med Research Associates | North Dartmouth | Massachusetts | 02747 | United States |
| St. Louis University School of Medicine | St Louis | Missouri | 63104 | United States |
| Midwest Allergy & Asthma Clinic | Omaha | Nebraska | 68114 | United States |
| Ocean Allergy & Respiratory Research Center | Brick | New Jersey | 08724 | United States |
| UMDNJ | Newark | New Jersey | 07101 | United States |
| Womes And childrens Hospital of Buffalo | Buffalo | New York | 14222 | United States |
| Asthma & Allergy Associates | Ithaca | New York | 14850 | United States |
| Allergy and Asthma Diagnostic Office | Liverpool | New York | 13088 | United States |
| Island Medical Research (Allergy and Asthma Center) | Rockville Centre | New York | 11570 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Allergy & Asthma Center of North carolina | High Point | North Carolina | 27262 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Resp Dis of Children and Adolescents | Oklahoma City | Oklahoma | 73112 | United States |
| Clinical Research Institute of Southern Oregon | Medford | Oregon | 97504 | United States |
| 501 Howard Av | Altoona | Pennsylvania | 16601 | United States |
| West Penn Allegheny General Health System | Pittsburgh | Pennsylvania | 15212 | United States |
| Asthma and Allergy Associates | Upland | Pennsylvania | 19013 | United States |
| AAPRI Clinical Research Institute | Lincoln | Rhode Island | 02865 | United States |
| Allergy Assoc., The ASthma, Allergy & Sinus Ctr | Knoxville | Tennessee | 37922 | United States |
| Vanderbilt University | Nashville | Tennessee | 37203 | United States |
| Pediatric Allergy/Immunology Associates, PA | Dallas | Texas | 75230 | United States |
| Pediatric Pulmonary Association of North Texas | Dallas | Texas | 75230 | United States |
| North Texas Institute for Clinical Trials | Fort Worth | Texas | 76132 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| 7707 Fannin/Ste. 195 | Houston | Texas | 77054 | United States |
| Sylvanna Research | San Antonio | Texas | 78229 | United States |
| Copperview Medical Center | South Jordan | Utah | 84095 | United States |
| Childrens Hospital of the Kings Daughters | Norfolk | Virginia | 23507 | United States |
| Virgina Commonwealth | Richmond | Virginia | 23219 | United States |
| A.S.T.H.M.A., Inc. | Seattle | Washington | 98105 | United States |
| 508 W 6th Av | Spokane | Washington | 99204 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 33223095 | Derived | Busse WW, Szefler SJ, Haselkorn T, Iqbal A, Ortiz B, Lanier BQ, Chipps BE. Possible Protective Effect of Omalizumab on Lung Function Decline in Patients Experiencing Asthma Exacerbations. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1201-1211. doi: 10.1016/j.jaip.2020.10.027. Epub 2020 Oct 24. |
| 32298853 | Derived | Szefler SJ, Casale TB, Haselkorn T, Yoo B, Ortiz B, Kattan M, Busse WW. Treatment Benefit with Omalizumab in Children by Indicators of Asthma Severity. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2673-2680.e3. doi: 10.1016/j.jaip.2020.03.033. Epub 2020 Apr 13. |
| 19910033 | Derived | Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009 Dec;124(6):1210-6. doi: 10.1016/j.jaci.2009.09.021. |
| FG001 | Placebo | Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab | Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
| BG001 | Placebo | Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question "How did you sleep last night?", with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement. | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period |
|
|
| ||||||||||||||||||||||||||||
| Primary | Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period | A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period. | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Posted | Mean | 95% Confidence Interval | Exacerbations per patient per 24-weeks | Baseline to end of the fixed-dose steroid treatment period (Week 24) |
| ||||||||||||||||||||||||||||||
| Secondary | Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period | A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period. | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Posted | Mean | 95% Confidence Interval | Exacerbations per patient per year | Baseline to end of the treatment period (Week 52) |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication. | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Posted | Mean | Standard Deviation | Puffs | Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24) | PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates. | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24) |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With at Least 1 Adverse Event | See Adverse Events module for details. | Safety population: All patients who received any study drug and had at least 1 post-baseline safety assessment. | Posted | Number | Percentage of participants | Baseline to end of the study (Week 68) |
|
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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 | Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. | 27 | 421 | 374 | 421 | ||
| EG001 | Placebo | Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. | 26 | 207 | 194 | 207 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis shigella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Medulloblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Tic | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis streptococcal | 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 |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | 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 |
| |
| Pharyngolaryngeal pain | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Placebo | Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
|
|
| Placebo |
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
|
|
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
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| OG001 | Placebo | Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. |
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