Tolerability of ALK Tree Tablet - Full Text View

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 I

MedlinePlus related topics:

Allergy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Parallel Assignment

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).

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

Sponsors and Collaborators

ALK-Abelló A/S

Investigators


Principal Investigator:	Kim Krogsgaard, MD	PhaseOne Trials

More Information

Study ID Numbers:	TT-01
First Received:	September 25, 2007
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00535639
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

Study placed in the following topic categories:

Hypersensitivity

Hypersensitivity, Immediate

Asthma

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	ALK-Abelló A/S
Information provided by:	ALK-Abelló A/S
ClinicalTrials.gov Identifier:	NCT00535639