hayfever tree allergy
Conditions
Interventions
Study medication and laboratory assessments
Sponsors
ALK B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained before entering the trial 2. Male or female aged 18-65 years 3. A documented clinically relevant history of birch pollen induced allergic rhinoconjunctivitis (with or without asthma), with uncontrolled symptoms despite having received symptomatic drug treatment during the birch pollen seasons 2011 and 2012 4. An appropriate minimum level of birch pollen allergic rhinoconjunctivitis symptoms corresponding to moderate to severe, defined as a total DSS score of (retrospective) score of at least >=8 on the worst day in the previous birch pollen season (e.g. 2 (on a scale from 0 to 3) on at least 4 out of 6 symptoms (4 nasal and 2 eye symptoms)) 5. Having experienced at least one of the following, due to allergic rhinoconjunctivitis during the previous birch pollen season: sleep disturbance, impairment of daily activities, leisure and/or sport, impairment of school or work, or troublesome symptoms 6. Positive SPT response (wheal diameter >= 3 mm larger than the negative control) to Betula verrucosa 7. Positive specific IgE against Bet v 1 (>= IgE Class 2; >=0.70 kU/L) at screening 8. Female subjects, who are fertile must have a negative pregnancy test and be willing to practise appropriate contraceptive methods until the end of trial 9. Subjects must be willing and able to comply with trial protocol regimens.
Exclusion criteria
Exclusion criteria: 1. A clinically relevant history of symptomatic seasonal allergic rhinitis and/or asthma, having received regular medication, due to another allergen source than birch, hazel, and alder, overlapping the birch pollen season 2. 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 3. A clinical history of uncontrolled asthma within 3 months prior to screening 4. Reduced lung function, defined as FEV1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average daily rhinoconjunctivitis symptom score during the entire BPS | — |
Secondary
| Measure | Time frame |
|---|---|
| The average rhinoconjunctivitis daily medication score (DMS) during the BPS The combined rhinoconjunctivitis symptom and medication score during the entire BPS. The average rhinoconjunctivitis DSS, average rhinoconjunctivitis DMS and average rhinoconjunctivitis DCS during the entire TPS (hazel, alder and birch) Well days/symptom and medication free days/Days with severe symptoms in the entire BPS and the entire TPS The average daily asthma symptom score during the entire BPS and the entire TPS Global evaluation in an overall comparison of this BPS compared to the previous BPS | — |
Countries
Netherlands
Outcome results
None listed