Tolerability of ALK Tree Tablet

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial is performed to assess the tolerability of the ALK Tree Tablet in patients with birch pollen induced allergy

• Phase: Phase 1

Details

• Lead Sponsor: ALK-Abelló A/S

Criteria

Inclusion Criteria:

• A clinical history of birch pollen induced rhinoconjunctivitis (with or without mild to moderate asthma ) of at least two years prior to trial entry requiring symptomatic treatment during the birch pollen season.

• Positive Skin Prick Test response to Betula verrucosa

• Positive specific IgE against Bet v1

• FEV1 ≥ 70% of predicted value

Exclusion Criteria:

• No clinical history of perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed and sensitised

• No clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis

• No conjunctivitis, rhinitis or asthma at the screening or randomisation visit

• No history of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis

• No history of angioedema