A phase IIIB trial investigating 3-year treatment efficacy, tolerability and safety of Grazax in children aged 5-18 years with grass pollen induced rhinoconjunctivitis with/without controlled controlled asthma ( three consecutive pollen seasons treatment) - GT-23

ALK-ABELLO`0 个研究点开始时间: 2009年12月2日最近更新: 2014年2月3日

适应症

试验速览

暂无简介。

•1.Boys and girls 5-18 years of age
•2.Written informed consent obtained from parents/guardians and from subjects if the level of intellectual maturity makes it appropriate.
•Assent will be obtained from subjects turning 18 during the trial.
•3.A clinical history of grass pollen induced allergic rhinoconjunctivitis with controlled or partly controlled asthma having received treatment during the previous grass pollen season.
•4.Positive Skin Prick Test (SPT) response (wheal diameter > 3 mm) to Phleum pratense
•5.Positive specific IgE against Phleum pratense( >IgE Class 2 )
•6.Female subject who are fertile, must have a negative pregnancy test. In case of female subjects adequate methods to avoid pregnancy should be used. (in case of pregnancy the subject will stop to take study medication and will be followed until delivery)
•7.Subject and parent/guardian willing and able to comply with trial protocol regimens.
•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

•1.A clinical history of symptomatic seasonal allergic rhinitis and asthma, having received regular medication, due to another allergen during-or potentially overlapping- the grass pollen season
•2.A clinical history of perennial allergic rhinitis and asthma having received regular medication due to an allergen to which the subject is regular exposed.
•3.A clinical history of chronic sinusitis during the last 2 years.
•4.A clinical history of severe asthma and/or a FEV1 <80%
•5.Any clinical relevant chronic disease such as hepatic or renal insufficiency, immunological diseases (Rheumatoid arthritis, lymphoma ect)
•6.Current severe atopic dermatitis
•7.Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
•8.History of anaphylaxis
•9.Chronic urticaria and angioedema.
•10.Immunosuppressive treatments (cyclosporine and other immunomodulating drugs such as metothrexate, azathioprine ) (except for steroids for allergic symptoms)
•11.History of allergy, hypersensitivity or intolerance to investigational medicinal product ( except for Phleum pratense) or rescue medications
•12.Unlike to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period.
•13.Being immediate family of the Investigator or trial staff, defined as the investigators/staffs child or grandchild.

发起方

ALK-ABELLO`