Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma

Multi-center, Open-label, Multiple Dose Study in Mild to Moderate Asthmatics (With IgE/Body Weight Combinations Above That in the SmPC Dosing Table) to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Omalizumab

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00546143

Enrollment

Registered

2007-10-18

Start date

2007-07-31

Completion date

Unknown

Last updated

2010-09-02

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

Brief summary

This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma

Interventions

DRUGOmalizumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of allergic asthma \>= 1 year duration and a history consistent with Step 2 or 3 clinical features from the Global Initiative for Asthma guidelines. * Eligible baseline serum immunoglobulin E (IgE) levels value and body-weight combinations

Exclusion criteria

* Documented medical history of anaphylaxis * Lung disease other than mild to moderate allergic asthma such as chronic obstructive pulmonary disease (COPD) Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of omalizumab assessed by AEs and SAEs	—

Secondary

Measure	Time frame
- Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels	—

Countries

Germany, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026