Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

An Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Adults and Adolescents With Severe Allergic Asthma Who Participated in the 52 Week CIGE250011E2 Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00482248

Enrollment

132

Registered

2007-06-05

Start date

2003-06-30

Completion date

2006-06-30

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, anti-immunoglobulin E, omalizumab, allergic asthma

Brief summary

This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.

Interventions

DRUGOmalizumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Inclusion criteria

* Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events * Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee

Exclusion criteria

* Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3 * Pregnant females or nursing mothers * Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.	—

Secondary

Measure	Time frame
Efficacy assessed by changes in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), the investigator's assessment of asthma control, corticosteroid use, the incidence of hospitalization and outpatients visits, and absenteeism fr	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026