Effect of Dupilumab in patients with allergic asthma, nasal polyps andaspirin intolerance
- Conditions
- Aspirin-exacerbated respiratory disease (AERD), also known as Samter'sTriad or Widal's triad, comprises the triad of allergic asthma, chronicrhinosinusitis with nasal polyps (CRswNP) and nonsteroidal antiinflammatorydrug (NSAID) intolerance. The prevalence of AERD remainsunclear. It is estimated that among patients with CRSwNP approximately30% have allergic asthma and 15% have aspirin intolerance.Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-004889-18-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
• Age 18 – 70
• Female and male patients
• Diagnosed with AERD (nasal polyps, asthma, aspirin intolerance)
o CRwNP (according to the European Position Paper on Rhinosinusitis
and Nasal Polyps Guidelines)8
o Documented aspirin intolerance
o Allergic asthma bronchiales diagnosed by a respiratory physician
(based on Global Initiative for Asthma guidelines)
Signed and dated informed consent form
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Pregnancy
• Clinically significant abnormal laboratory values and active infection
(Tbc, HIV, hepatitis A/B/C)
• History of malignancy or immunodeficiency
• Chronic obstructive lung disorders (COPD), other obstructive lung
disorders (bronchiolitis)
• Need for systemic corticosteroid therapy 1 month prior to screening
visit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method