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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010937-38 | EudraCT Number |
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This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Experimental | Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. |
|
| Placebo | Placebo Comparator | Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omalizumab | Drug | Omalizumab was supplied in 5mL vials with solution for subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils | Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value. | Baseline and 16 weeks |
| Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells | Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value. | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fractional Exhaled Nitric Oxide (FeNO) | FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value. | Baseline and 4, 8, 12 and 16 weeks |
| Change From Baseline in Induced Sputum Eosinophil Count |
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Inclusion Criteria:
Severe persistent asthma with the following characteristics:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Arnaud de Villeneuve | France | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23579324 | Derived | Garcia G, Magnan A, Chiron R, Contin-Bordes C, Berger P, Taille C, Devouassoux G, de Blay F, Couderc LJ, Didier A, O'Callaghan DS, Girodet PO, Bourdeix I, Le Gros V, Humbert M. A proof-of-concept, randomized, controlled trial of omalizumab in patients with severe, difficult-to-control, nonatopic asthma. Chest. 2013 Aug;144(2):411-419. doi: 10.1378/chest.12-1961. |
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79 patients were screened. 41 patients received study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab | Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. |
| FG001 | Placebo | Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab | Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. |
| BG001 | Placebo | Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks. |
| 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 the Expression of FcεRI Receptors of Blood Basophils | Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value. | Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI | Posted | Mean | Standard Deviation | Percent change in MFI | Baseline and 16 weeks |
|
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Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
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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 subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac 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 supplied in vials with solution for subcutaneous injection. |
|
The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value. |
| Baseline and 16 weeks |
| Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist) | The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement. | Baseline and 16 weeks |
| Change From Baseline in Nasal Symptom Global Score and Individual Components | Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores. | Baseline and 16 weeks |
| Physician and Patient Global Evaluation of Treatment Effectiveness | The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment. | 16 weeks |
| Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks | Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1. | Baseline and 16 weeks |
| Number of Patients With at Least One Asthma-related Event Over 16 Weeks | Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit. | 16 weeks |
| Béthune |
| France |
| Novartis Investigative Site | Bordeaux | France |
| Novartis Investigative Site | Clamart | France |
| Novartis Investigative Site | Lyon | France |
| Novartis Investigative Site | Nantes | France |
| Novartis Investigative Site | Paris | France |
| Novartis Investigative Site | Strasbourg | France |
| Novartis Investigative Site | Suresnes | France |
| Novartis Investigative Site | Toulouse | France |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks. |
|
|
| Secondary | Change in Fractional Exhaled Nitric Oxide (FeNO) | FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value. | Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. During different time points, participants with observations at that time point were included in the analysis. | Posted | Mean | Standard Deviation | parts per billion (ppb) | Baseline and 4, 8, 12 and 16 weeks |
|
|
|
| Secondary | Change From Baseline in Induced Sputum Eosinophil Count | The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value. | Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. Only patients with measurements at both baseline and week 16 were included in this analysis. | Posted | Mean | Standard Deviation | Percentage of total nonsquamous cells | Baseline and 16 weeks |
|
|
|
| Secondary | Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist) | The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement. | Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment | Posted | Mean | Standard Deviation | Score units | Baseline and 16 weeks |
|
|
|
| Secondary | Change From Baseline in Nasal Symptom Global Score and Individual Components | Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores. | Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment | Posted | Mean | Standard Deviation | Score units | Baseline and 16 weeks |
|
|
|
| Secondary | Physician and Patient Global Evaluation of Treatment Effectiveness | The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment. | Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment | Posted | Number | Participants | 16 weeks |
|
|
|
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks | Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1. | Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment | Posted | Mean | Standard Deviation | Liters | Baseline and 16 weeks |
|
|
|
| Secondary | Number of Patients With at Least One Asthma-related Event Over 16 Weeks | Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit. | Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment | Posted | Number | Participants | 16 weeks |
|
|
|
| Primary | Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells | Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value. | Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI | Posted | Mean | Standard Deviation | Percent change in MFI | Baseline and 16 weeks |
|
|
|
| 2 |
| 20 |
| 16 |
| 20 |
| EG001 | Placebo | Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks. | 1 | 21 | 16 | 21 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Lip oedema | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | 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 |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | 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 |
| Week 12 (N = 19, 18) |
|
| Week 16 (N = 18, 19) |
|
| Symptoms on waking |
|
| Activity limitation |
|
| Shortness of breath |
|
| Wheeze (N = 19, 21) |
|
| Use of rescue short-acting β2-agonist |
|
| Runny nose |
|
| Congestion |
|
| Itchy nose |
|
| Postnasal drip |
|
| Nasal symptoms overall |
|
| Physician's evaluation - Moderate |
|
| Physician's evaluation - Poor |
|
| Physician's evaluation - Worsening |
|
| Patient's evaluation - Excellent |
|
| Patient's evaluation - Good |
|
| Patient's evaluation - Moderate |
|
| Patient's evaluation - Poor |
|
| Patient's evaluation - Worsening |
|