Overview

This trial has been completed.

Condition allergic asthma
Treatment omalizumab
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date March 2011
End date December 2013
Trial size 38 participants
Trial identifier NCT01328886, CIGE025B1301E1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
omalizumab
omalizumab lyophilized 150 mg injection

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
time frame: 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)
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

Eligibility Criteria

Male or female participants from 6 years up to 15 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Novartis.