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NCT00535639 Clinical Trial

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
Secondary ID
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. completion date
Est. primary completion date December 2007
Accepts healthy volunteers
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

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, 

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