A multicentre randomised placebo-controlled, double-blind clinical trial for eval¬ua¬tion of safety and efficacy of pre-seasonal specific immunotherapy with a hypoallergenic extract of a 6 grass and rye (Grasses plus Rye) pollen mixture in patients with rhinoconjunctivitis +/- asthma bronchiale

Femme et Homme

| Pays :
| Organes :
| Spécialités :

Extrait

The aim of this CT is to prove the hypothesis that the allergoid preparation of an extract of a grasses plus rye pollen mixture is suitable for an efficacious treatment of grass pollen allergic patients with SIT and that the trial preparation is sufficient to suppress allergic symptoms caused by natural grass pollen exposure. A quantitative Conjunctival Provocation Test (CPT) will be performed before treatment to determine the individual threshold concentration defined by the lowest concentration of a grass plus rye pollen extract eliciting a positive allergic reaction (irritation/pruritus and redness/hyperemia) in the conjunctiva of a patient. Primary endpoint is o determine the number of patients with an improvement of the threshold concentration in October 2009 after 2 years of treatment a CPT with the individual threshold concentration only will be performed.

Critère d'inclusion

IgE-mediated allergic diseases including symptoms of allergic rhinoconjunctivitis, controlled allergic bronchial asthma, triggered by grass/rye pollen allergens

Liens

ictrp
euctr

Kusajili – Centralise les essais cliniques mondiaux

A multicentre randomised placebo-controlled, double-blind clinical trial for eval¬ua¬tion of safety and efficacy of pre-seasonal specific immunotherapy with a hypoallergenic extract of a 6 grass and r...