Depigoid Birch 5000 Longterm Study in Adults and Adolescents

Exclusion Criteria

• •History of significant clinical manifestations of allergy as a result of sensitization against co-allergies, particularly-but not limited to-grass or weed pollen and perennial allergens (e.g. house dust mites, cat or dog).
• •History of anaphylactic reaction.
• •Moderate or severe persistent asthma (GINA 3 or 4).
• •Mild persistent asthma (GINA 2), according to the Global Initiative for Asthma Guidelines, necessitating treatment with inhaled glucocorticoids at a daily dose level of \> 400 µg budesonide dose equivalents.
• •Lung function \< 80% of the predicted normal value (for PEF: highest result of 3 measurements).
• •Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis.
• •Chronic structural diseases of the affected organs (e.g. eye, nose, lung).
• •History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.
• •Any disease that prohibits the use of adrenaline (e.g. hyperthyroidism).
• •Atopic dermatitis with SCORAD \>30 in the past or at screening.
• •Ongoing or past full courses of SIT against birch pollen within the last 5 years.
• •Topical and systemic treatment with β-blockers.
• •Concomitant treatment with substances interfering with the immune system beginning 1 week prior to start of treatment.
• •Use of systemic corticosteroids within 3 months prior to Visit 1-1.
• •Immunization with vaccines within 7 days prior to Visit 1-1.
• •Treatment with antihistamines for any reason other than allergic symptoms due to birch pollen allergy.
• •Changed residence between geographical regions since the last birch pollen season or not staying in the geographical region during the pre-determined birch pollen season.
• •Nursing (lactating) women or women with a positive pregnancy test at the screening visit. Women of childbearing potential must be using highly effective contraception during participation in this clinical study. A highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomised partner.