Is Intralymphatic Allergen Immunotherapy effective and safe: A human randomized clinical trial - Intralympatic ASIT
- Conditions
- Seasonal Allergic rhinitis due to pollen from grass and betula verrucosa
- Registration Number
- EUCTR2009-016815-39-SE
- Lead Sponsor
- Allergy Unit Department of Oto-rhino-Laryngology Lund/Malmö University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
- Age 18-65,
- Seasonal allergic symptoms for grass verified by skin prick test,
- Accepted informed consent.
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) no
F.1.3.1 Number of subjects for this age range
- Pregnancy or nursing,
- Autoimmune or collagen disease (known),
- Cardiovascular disease,
- Perennial pulmonary disease,
- Hepatic disease,
- Renal disease,
- Cancer,
- Any medication with a possible side-effect of interfering with the immune response,
- Previous immuno- or chemotherapy,
- Chronic diseases,
- Upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease),
- Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with ß-blockers),
- Major metabolic disease,
- Known or suspected allergy to the study product,
- Alcohol or drug abuse,
- Mental incapability of coping with the study,
- Withdrawal of informed consent.
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