A Phase III trial assessing the pharmacodynamic efficacy and the tolerability of Grazax® treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis - Grazax® in-season

ALK-Abelló A/S0 个研究点目标入组 250 人开始时间: 2008年5月15日最近更新: 2012年3月19日

研究概览

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•- A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms, which remain troublesome despite treatment with anti-allergic drugs during the GPS of two years or more
•- A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms during GPS causing symptoms more the 4 days per week (for > 4 weeks)
•- A clinical history of significant persistent rhinoconjunctivitis symptoms during GPS causing least one of the a-d symptoms
•a.Abnormal sleep
•b.Impairment of daily activities, sports, leisure
•c.Impaired work and school
•d.Troublesome symptoms
•- Positive specific IgE against Phleum pratense (= IgE Class 2)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•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

•- Uncontrolled asthma in the past 12 months
•- FEV1 < 70% of predicted value after adequate pharmacologic treatment
•- Inflammatory condition in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis
•- History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
•- History of facial angioedema in GPS or presence of facial angioedema at time of randomization
•- History of swallowing difficulties in GPS or presence of swallowing difficulties at time of randomization
•- History of allergy symptoms in the GPS leading to hospital admission
•- History of allergy symptoms in the GPS leading to treatment with corticosteroids other than topical corticosteroids

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