Tolerability of ALK Tree Tablet

Phase 1

Completed

• Conditions: Allergy

• Registration Number: NCT00535639
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-25
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Study Start: 2007-10
• Primary Completion: 2007-12
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-28
• Last Update Posted: 2008-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

PhaseOne Trials; 🇩🇰 Hvidovre, Denmark