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Tolerability of ALK Tree Tablet

NCT ID: NCT00535639

Last Updated: 2008-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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

Detailed Description

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Conditions

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Allergy

Keywords

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Tolerability of ALK Tree Tablet in patients with birch pollen induced allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Betula Verrucosa allergen extract

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kim Krogsgaard, MD

Role: PRINCIPAL_INVESTIGATOR

PhaseOne Trials

Locations

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PhaseOne Trials

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TT-01

Identifier Type: -

Identifier Source: org_study_id