Clinical trial NCT01328886: Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children
Official title: An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite Current Recommended Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Asthma
Keywords: omalizumab
allergic asthma
pediatric patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-05
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

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.

Primary outcomes:
measure: To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs
timeFrame: Every 3 months for approximately 2 years
Secondary outcomes:
measure: To explore the efficacy of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC)
timeFrame: Every 3 months for approximately 2 years
measure: 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))
timeFrame: Every 3 months for approximately 2 years
measure: To explore the efficacy of omalizumab by use of asthma long-term control medications
timeFrame: Every 3 months for approximately 2 years
measure: To explore the efficacy of omalizumab by Pulmonary function (FEV1, FVC, V(・)50, V(・)25 and FEF25-75%)
timeFrame: Every 3 months for approximately 2 years
measure: To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma
timeFrame: Every 3 months for approximately 2 years
Other outcomes:
Locations:
city: Ohbu
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Tsu
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Tenri
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Habikino city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Shimotsuka-gun
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Fuchu
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Komae
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Sumida-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Gifu
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Odajima H, Ebisawa M, Nagakura T, Fujisawa T, Akasawa A, Ito K, Doi S, Yamaguchi K, Katsunuma T, Kurihara K, Teramoto T, Sugai K, Nambu M, Hoshioka A, Yoshihara S, Sato N, Seko N, Nishima S. Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma. Allergol Int. 2017 Jan;66(1):106-115. doi: 10.1016/j.alit.2016.06.004. Epub 2016 Aug 6.