Tolerability of ALK Tree Tablet

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00535639
First received: September 25, 2007
Last updated: February 28, 2008
Last verified: February 2008
  Purpose

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


Condition Intervention Phase
Allergy
Drug: Betula Verrucosa allergen extract
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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).

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Study Start Date: October 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535639

Locations
Denmark
PhaseOne Trials
Hvidovre, Denmark, 2650
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Principal Investigator: Kim Krogsgaard, MD PhaseOne Trials
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00535639     History of Changes
Other Study ID Numbers: TT-01
Study First Received: September 25, 2007
Last Updated: February 28, 2008
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by ALK-Abelló A/S:
Tolerability of ALK Tree Tablet in patients with birch pollen induced allergy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014