Tolerability of ALK Tree Tablet

Allergy Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535639
• Other study ID #: TT-01
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2007
• Last updated: February 28, 2008
• Start date: October 2007

Study information

• Verified date: February 2008
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: December 2007
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• Betula Verrucosa allergen extract

Locations

Country	Name	City	State
Denmark	PhaseOne Trials	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Denmark,