Effect of Omalizumab in patients with Aspirin intolerance, nasal polyposis and allergic asthma

Effect of Omalizumab in patients with Aspirin-Exazerbated Respiratory Disease (AERD)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003119-21-AT

Enrollment

Registered

2017-09-08

Start date

2017-12-22

Completion date

Unknown

Last updated

2026-05-18

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

Conditions

Aspirin-exacerbated respiratory disease (AERD), also known as Samter's triad or Widal's triad, comprises the triad of Asthma, chronic rhinosinusitis with nasal polyps (CRwNP) and nonsteroidal anti-inflammatory drug (NSAID) intolerance

Interventions

Trade Name: Xolair (Omalizumab) Pharmaceutical Form: Injection INN or Proposed INN: OMALIZUMAB CAS Number: 242138-07-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Signed and dated informed consent form -Age 18-70 years -Male or female -Diagnosed with AERD 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy Clinically significant abnormal laboratory values and active infection (Tbs, HIV, Hepatitis A/B/C) History of malignancy or immunodeficiency

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the efficacy of omalizumab in patients with AERD regarding intolerance of salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of omalizumab Treatment.;Secondary Objective: To analyze the effects before and after 6 months of omalizumab Treatment on blood-related and Skin-related biomarkers of patients with AERD: -Serum ECP, total IgE, Tryptase -peripheral blood eosinophils -reduction in total nasal endoscopic polyp scores after 6 months of Treatment (TPSs) -reduction of Sino-Nasal Outcome Test-20 (SNOT-20), which measures the quality of life of patients with chronic rhinosinusitis -reduction of allergic Asthma measured by spiromety and asthma control score;Primary end point(s): The Primary endpoint is the efficacy of omalizumab in the treatment of patients with AERD regarding the intolerance of salicylic acid after 6 months of Treatment. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of omalizumab Treatment.;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To test the efficacy of omalizumab in patients with AERD regarding intolerance of salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of omalizumab Treatment.;Secondary Objective: To analyze the effects before and after 6 months of omalizumab Treatment on blood-related and Skin-related biomarkers of patients with AERD: -Serum ECP, total IgE, Tryptase -peripheral blood eosinophils -reduction in total nasal endoscopic polyp scores after 6 months of Treatment (TPSs) -reduction of Sino-Nasal Outcome Test-20 (SNOT-20), which measures the quality of life of patients with chronic rhinosinusitis -reduction of allergic Asthma measured by spiromety and asthma control score;Primary end point(s): The Primary endpoint is the efficacy of omalizumab in the treatment of patients with AERD regarding the intolerance of salicylic acid after 6 months of Treatment. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of omalizumab Treatment.;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): -Reduction of polyps after 6 months of treatment, this will be evaluated by an ENT specialist. The polyps will be evaluated on each side by means of nasal endoscopy and grated based on polyp size, resulting in scores of 0 to 4 (TPSs) -Reduction of allergic Asthma, measured by spirometry and Asthma control score.;Timepoint(s) of evaluation of this end point: 6 months	—

Countries

Austria

Contacts

Public ContactUniv.Prof. Dr. Georg Stingl

Medical University of Vienna

georg.stingl@meduniwien.ac.at004314040077050

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: May 22, 2026