A randomised, double-blind, placebo-controlled, multi-centre Phase I Trial investigating the safety of GRAZAX-R in children aged 5-12 years with grass pollen induced rhinoconjunctivitis (with/without asthma)
- Conditions
- IgE mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthma
- Registration Number
- EUCTR2005-005402-22-DE
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
- Boys and girls 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 of at least 3 mm) to Phleum pratense
- Positive specific IgE against Phleum pratense (at least 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: N/A;Primary end point(s): Adverse events;Main Objective: To investigate the tolerability of Grazax in children aged 5-12 years.
- Secondary Outcome Measures
Name Time Method