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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
History of Changes
  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:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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 May 21, 2013