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

Phase 1

• 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; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-003119-21-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-08
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified