IgE Mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthma
Conditions
Interventions
Product Name: GRAZAX
Product Code: ALK Grass tablet
Pharmaceutical Form: Oral lyophilisate
Pharmaceutical form of the placebo: Soluble tablet
Route of administration of the placebo: Sublingual use
Sponsors
ALK-Abello, Group Clinical Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • To investigate the efficacy and safety of Grazax based on the following information: ? Rhinoconjunctivitis symptom and medication scores in the peak grass pollen season ? Asthma symptom and medication score in the grass pollen season ? Asthma symptom and medication score in the peak grass pollen season ? Pharmacoeconomic data in the grass pollen season ? Safety Assessments at screening and End of treatment Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Current food allergies with oral allergy syndrome 2. A clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication due to another allergen during – or potentially overlapping - the grass pollen season. 3. A clinical history of perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed 4. A clinical history of chronic sinusitis during the last 2 years 5. A clinical history of severe asthma (Step 4, according to GINA definition) 6. Any clinical relevant chronic disease 7. Current severe atopic dermatitis 8. Use of an investigational drug within 30 days prior to screening 9. Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years 10. Use of any of the following drugs within the time indicated prior to randomisation or during the study period unless provided as rescue medication:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of specific immunotherapy with Grazax compared to placebo, in children with grass pollen induced allergic rhinoconjunctivitis.;Primary end point(s): ;Secondary Objective: • To investigate the efficacy and safety of Grazax based on the following information: ? Rhinoconjunctivitis symptom and medication scores in the peak grass pollen season ? Asthma symptom and medication score in the grass pollen season ? Asthma symptom and medication score in the peak grass pollen season ? Pharmacoeconomic data in the grass pollen season ? Safety Assessments at screening and End of treatment | — |
Countries
Germany
Outcome results
None listed