Tolerability of ALK Tree Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00535639
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : February 29, 2008
Information provided by:
ALK-Abelló A/S

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

Condition or disease Intervention/treatment Phase
Allergy Drug: Betula Verrucosa allergen extract Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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).
Study Start Date : October 2007
Actual Primary Completion Date : December 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00535639

PhaseOne Trials
Hvidovre, Denmark, 2650
Sponsors and Collaborators
ALK-Abelló A/S
Principal Investigator: Kim Krogsgaard, MD PhaseOne Trials Identifier: NCT00535639     History of Changes
Other Study ID Numbers: TT-01
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: February 29, 2008
Last Verified: February 2008

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