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OpenTrials
Completed

NCT Number: NCT00535639

Tolerability of ALK Tree Tablet

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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PhaseOne Trials

Hvidovre, 2650, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betula Verrucosa allergen extract

Drug

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study 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).

Important dates

Study start
2007
Primary completion
2007
First posted
Sep 26, 2007
Registry last updated
Feb 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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