Allergic Asthma
Conditions
Sponsors
Novartis Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who completed the core study (IGE025B1301) and who in the investigator's clinical judgment could benefit from continuous treatment of the study drug. Are the trial subjects under 18? yes Number of subjects for this age range: 38 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: •Patients who currently have diagnosed cancer, are currently being investigated for possible cancer or have any history of cancer. •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means; using a highly effective method of birth control; or agreeing on total abstinence and the investigator also judges that the age, career lifestyle or sexual orientation of the patient ensures compliance. •With clinically significant uncontrolled systemic disease (eg: infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, cerebro-vascular, endocrinologic or gastrointestinal disease) after the treatment period of the core study. •Patients with a history of major protocol violations during the core study and who are considered potentially unreliable as judged by the investigator at each site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs ;Secondary Objective: Exploratory Objectives: •To explore the effect of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC) •To explore the effect of omalizumab by QOL questionnaire score (Quality of life questionnaires for pediatric patients with bronchial asthma and their parents or caregivers (Gifu)) •To explore the effect of omalizumab by use of asthma long-term control medications •To explore the effect of omalizumab by Pulmonary function (FEV1, FVC, V(·)50, V(·)25 and FEF25-75%) •To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma •To collect the data of PK and PD in Japanese pediatric patients;Primary end point(s): To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs ;Timepoint(s) of evaluation of this end point: Every 3 months for approximately 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory •To explore the effect of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC) •To explore the effect of omalizumab by QOL questionnaire score (Quality of life questionnaires for pediatric patients with bronchial asthma and their parents or caregivers (Gifu)) •To explore the effect of omalizumab by use of asthma long-term control medications •To explore the effect of omalizumab by Pulmonary function (FEV1, FVC, V(·)50, V(·)25 and FEF25-75%) •To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma •To collect the data of PK and PD in Japanese pediatric patients;Timepoint(s) of evaluation of this end point: The assessments of asthma control and QOL, and spirometry measurements were performed every 3 months. Laboratory safety assessments were performed at 1 month, 3 months and 6 months after the first dose of the study drug at Visit 1 and every 6 months thereafter. PK and PD (serum free IgE levels) evaluation was also evaluated every 6 months. | — |
Countries
Japan
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed