Korrelation von freiem IgE mit klinischen Parametern bei Asthma-Patienten unter Therapie mit Omalizumab, einem monoklonalen Antikörper gegen körpereigenes IgE - Freies IgE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012108-15-DE

Enrollment

Registered

2009-04-24

Start date

2009-06-19

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Add-on therapy to improve asthma control in patients 18-75 years of age with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Interventions

Trade Name: Xolair 150 mg powder and solvent for solution for injection Pharmaceutical Form: Injection* INN or Proposed INN: omalizumab CAS Number: 242138-07-4 Other descriptive name: OMALIZUMAB Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Provision of informed consent Indication for Xolair as earlier described according to the MA in the EU Age 18 – 75 years Outpatients of either sex Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known or suspected hypersensitivity to study therapy Pregnancy or planned pregnancy during study Women of child-bearing potential not using acceptable contraceptive measures insulin-dependent diabetes mellitus chronic renal insuffiency clinically relevant heaptic insuffiency respiratory infection 4 weeks prior to inclusion participating in a clinical study during the last 30 days

Design outcomes

Primary

Measure	Time frame
Main Objective: Correlation of free serum IgE with clinical parameters of asthma control ;Secondary Objective: Correlation of free serum IgE with clinical parameters (lung function, differential blood count, nitric oxide (FeNO), immune cell function tests, sputum eosinophils, quality of life, symptoms) ;Primary end point(s): asthma control as a function of levels of free IgE	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026