This trial is to test which dose of a dispersible tablet containing birch pollen allergens can improve hay fever symptoms and reduce the need for symptomatic allergy medication.

• Conditions: Subjects with a documented clinically relevant history of moderate to severe birch pollen induced allergic rhinoconjunctivitis (with or without asthma) with symptoms despite having received symptomatic medication.; MedDRA version: 16.0Level: LLTClassification code 10066093Term: Birch pollen allergySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-000031-59-LT
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-08
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Male or females aged 12-65 (adolescents ages 12 - <18 years will only be recruited in selected countries).
Subjectcs with a documented clinical relevant history of moderate to severe birch pollen induced allergic rhinoconjunctivitis (with or without asthma) with symptoms despite having received symptomatic medication.
Subjects with a minimum level of birch pollen allergic rhinoconjunctivitis symptoms.
Presence of one or more of the following ARIA quality of life items during the previous birch pollen season: a. Sleep disturbance, b. Impairment of daily activities, leisure and/or sport, c. Impairment of school or work, d. Troublesome symptoms
A positive SPT response (wheal diameter = 3 mm larger than the negative control to Betula verrucosa)
Positive specific IgE against Bet v1 (= IgE Class 2, =0.70 kU/L) at screening.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A clinically relevant history of perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed.
A clinical history of uncontrolled asthma within 3 month prior to randomisation
Reduced lung function, defined as FEV-1 < 70% of predicted value after adequate pharmacological treatment.
Previous treatment with immunotherapy with birch pollen allergen - or a cross-reacting allergen such as hazel or alder.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify an optimal dose interval with respect to efficacy and safety for the ALK tree AIT in adults and adolescents with moderate to severe birch pollen induced allergic rhinoconjunctivitis.;Secondary Objective: To evaluate the quality of life related to rhinoconjunctivitis during treatment with the ALK tree AIT.<br>To investigate the immunological response to the ALK tree AIT;Primary end point(s): The primary efficacy endpoint is the avarage rhinoconjunctivitis daily symptom score during the birch pollen season, calculated for each subject as the sum of the rhinoconjunctivitis daily symptom score during the birch pollen season divided by the number of days with diary records in the birch pollen season.;Timepoint(s) of evaluation of this end point: By the end of trial - there are no interim analyses planned.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoints comprises of:<br>The average rhinoconjunctivitis daily medication score during the birch pollen season calculated for each subject as the sum of rhinoconjunctivitis daily symptom score during the birch pollen season divided by the number of days with diary records in the birch pollen season.<br>The combined rhinoconjunctivitis symptom and medication score during the entire birch pollen season. <br>The average rhinoconjunctivitis daily symptom score, average rhinoconjunctivitis daily medication score during the entire tree pollen season.;Timepoint(s) of evaluation of this end point: By the end of trial - there are no interim analyses planned.