A Randomised, Multiple Dose, Dose Escalation, Double-Blind, Placebo-Controlled Phase I Study Investigating the Safety of ALK Tree Tablet in Adult Subjects With Birch Pollen Induced Rhinoconjunctivitis (With/Without Asthma).

ALK-Abelló A/S1 site in 1 countryStarted: October 1, 2007Last updated: February 29, 2008

Conditions

Drugs

Trial Snapshot

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

•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

•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

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