Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. The term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

Criteria

Inclusion criteria:

1. Patients must experience significant allergic symptoms on visit 2

2. Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens

3. Specific IgE against birch allergens (CAP RAST ≥ 2)

Exclusion criteria:

1. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens

2. FEV1 or PEF value ≤ 80 %

3. Persistent asthma (GINA ≥ 2)

Other protocol-defined inclusion/exclusion criteria may apply.