To prevent development of asthma - 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. MedDRA version: 12.0 Level: PT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: GRAZAX
Product Name: Grazax
Pharmaceutical Form: Orodispersible tablet
Pharmaceutical form of the placebo: Orodispersible tablet
Route of administration of the placebo: Sublingual use
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Grazax compared to placebo on the risk 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 developing asthma during grass pollen season (GPS) after three treatment years and three treatment years plus to post-treatment years. 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. 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 Time of onset of asthma during five years (three treatment years plus two post-treatment years) | — |
Countries
Austria, Denmark, Finland, France, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed