GAP Grazax Asthma Prevention - GAP
- Conditions
- The aim of the trial is to investigate whether three consecutive years of treatment with Grazax (75.000 SQ-T) reduces the risk of developing asthma in children compared to placebo.
- Registration Number
- EUCTR2009-011235-12-FI
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 812
Females and males 5-12 years of age at time of randomisation
Written informed consent obtained from parents/guardians
Assent from subject, according to national guidelines
A clinical relevant history of grass pollen induced allergic rhino-conjuctivitis having received symptomatic treatment during the GPS 2009 and 2010,
Positive Skin Prick Test (SPT) reponse (wheal diameter = 3 mm) to Phleum pratense
Positive specific IgE against Phleum Pratense (= IgE Class 2)
Female subjects, who are fertile must have a negative pregnancy test
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
A clinical relevant history of symptomatic seasonal allergic rhinitis and/or conjunctivitis caused by an allergen other than grass overlapping the GPS.
A clinical relevant history of symptomatic perennial allergic rhinitis and/or conjuctivitis caused by an allergen, to which the subject is regularly exposed.
Not capable of perfoming reproducible lung function tests
A medical history of astma and/or wheezing within the last two years.
A medical hsiotry of asthma and/or wheezing since the 5th birthday.
Use of asthma medication within the last 12 month, to treat respiratory and/or pulmonary symptoms which resulted in a clinical relevant effect.
An increase in FEV-1 of = 12% after administration of a beta-2-agonist
Investigator diagnosed asthma
Diurnal PEF variability > 20% for at least 3 out of 14 consecutive days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of Grazax compared to placebo on the risk of developing asthma during three treatment years and three treatment years plus two post-treatment years;Secondary Objective: To investigate the effect of Grazax compared to placebo on the risk of developing asthma during grass pollen season (GPS) after three treatment years and three treatment years plus to post-treatment years.<br><br>To investigate the proportion of subjects with and without asthma when comparing Grazax and placebo after three treatment years and three treatment years plus two post-treatment years.<br><br>To investigate the efficacy of Grazax compared to placebo based on visual analogue scale (VAS) scoring of rhinoconjunctivitis symptoms in the GPS;Primary end point(s): Time of onset of asthma during three treatment years<br>Time of onset of asthma during five years (three treatment years plus two post-treatment years)<br>
- Secondary Outcome Measures
Name Time Method