A treatment study of 10 adult persons with injection of grass- or birch pollen in a lymph nodule with one month in between - for treatment of pollen allergy.

• Conditions: Allergic rhinoconjunctivitis; MedDRA version: 15.0Level: PTClassification code 10048908Term: Seasonal allergySystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-004088-38-SE
• Lead Sponsor: Allergy Centre, University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-01
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age 18-50 years,
Seasonal allergic symptoms for grass or birch verified by skin prick test.
Accepted and signed 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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The presence of any of the following will exclude the potential study
patient from entry into the study:
Pregnancy or nursing, or planning for that. Women with childbearing
potential should use contraceptives. Condom only is not enough as
contraceptive.
Autoimmune or collagen disease
Grave cardiovascular disease, milder cases decided by the investigator
Perennial pulmonary disease, FEV1 < 80 % of predicted, or use of more
then 400 microgram budesonide (or equivalent/day)
Recent or on-going hepatic disease
Recent or on-going renal disease
Cancer – as decided by the investigator
Any medication with a possible side effect of interfering with the
immune response, Previous immuno- or chemotherapy
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 Beta-blockers)
Major metabolic disease
Known or suspected allergy for addatives in the study product
Alcohol or drug abuse
Mental incapability of coping with the study
Participation in another clinical study within 30 days that could jeopardize this study

Study & Design

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