Prevención de Asma mediante Grazax - GAP

Conditions: Prevención de asma en pacientes con rinoconjuntivitis.

Registration Number: EUCTR2009-011235-12-ES

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:
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 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