GAP

Conditions: The trial will be carried out in children (aged 5 - 12 years at study onset) with rhinoconjunctivitis caused by grass pollen allergy. The aim of the trial is to investigate whether three consecutive years of treatment with Grazax (75.000 SQ-T) reduce the risk of developing asthma compared to placebo.
MedDRA version: 17.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2009-011235-12-DE

Lead Sponsor: ALK-Abelló A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 620

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: 620
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

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 months, 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.;Secondary Objective: To investigate the effect of Grazax compared to placebo on the risk of developing asthma during the grass pollen season (GPS).<br><br>To investigate the proportion of subjects with and without asthma when comparing Grazax and placebo at end of trial.<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 to onset of asthma.;Timepoint(s) of evaluation of this end point: The evaluation of the primary end point will be performed after the end of the trial.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to onset of asthma in GPS.<br><br>Asthma status (yes/no) (i.e. status of being asthma symptom free since last visit) at end of trial visit.<br><br>Average VAS score of rhinoconjunctivitis symptoms.<br><br><br>Asthma symptom free since last visit is defined as when a subject is<br>neither under treatment for asthma nor has experienced asthma<br>symptoms (any episodes of wheeze, cough, shortness of breath or chest<br>tightness) since last visit.;Timepoint(s) of evaluation of this end point: The evaluation of the secondary end points will be performed after the end of the trial.