IgE mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthma. – Alergia mediada por IgE (Rinoconjuntivitis) a polen de gramíneas (Hierba Timotea, Phleum pratense) con o sin asma.
Conditions
Interventions
Trade Name: ALK grass tablet phleum pratense
Product Name: Grazax
Product Code: ALK Grass tablet
Pharmaceutical Form: Oral lyophilisate
Other descriptive name: Major allergen Group 5 Phleum pratense
C
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female 5-12 years of age - A clinical history of grass pollen induced allergic rhinoconjunctivitis requiring treatment during at least one grass pollen season - Positive Skin Prick Test (SPT) response (wheal diameter = 3 mm) to Phleum pratense - Positive specific IgE against Phleum pratense (= 0.7 kU/ml) 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: - Current food allergies with oral allergy syndrome - A clinical history of severe asthma - At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process - Current severe atopic dermatitis - History of anaphylaxis or angioedema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the tolerability of ALK Grass tablet in children aged 5-12 years.;Secondary Objective: N/A;Primary end point(s): Adverse events | — |
Countries
Spain
Outcome results
None listed