The purpose of this extension study is to assess the long-term safety and tolerability of omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with inadequately controlled allergic asthma despite current recommended treatment by providing continued treatment with omalizumab to patients who have previously completed the core study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
omalizumab lyophilized 150 mg injection
Novartis Investigative Site
Ohbu, Aichi-ken, Japan
Novartis Investigative Site
Chiba, Chiba, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs
Time frame: Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC)
Time frame: Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by QOL questionnaire score (Quality of life questionnaires for pediatric patients with bronchial asthma and their parents or caregivers (Gifu))
Time frame: Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by use of asthma long-term control medications
Time frame: Every 3 months for approximately 2 years
To explore the efficacy of omalizumab by Pulmonary function (FEV1, FVC, V(・)50, V(・)25 and FEF25-75%)
Time frame: Every 3 months for approximately 2 years
To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma
Time frame: Every 3 months for approximately 2 years
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Novartis Investigative Site
Gifu, Gifu, Japan
Novartis Investigative Site
Sagamihara, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Tsu, Mie-ken, Japan
Novartis Investigative Site
Tenri, Nara, Japan
Novartis Investigative Site
Habikino, Osaka, Japan
...and 5 more locations