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 controlled asthma) with symptoms despite having received symptomatic medication.Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-000031-59-PL
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
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
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
- Secondary Outcome Measures
Name Time Method