Tolerability of ALK Tree Tablet

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).

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00535639

Enrollment

Unknown

Registered

2007-09-26

Start date

2007-10-31

Completion date

Unknown

Last updated

2008-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Tolerability of ALK Tree Tablet in patients with birch pollen induced allergy

Brief summary

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

Interventions

DRUGBetula Verrucosa allergen extract

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026