An open trial to assess the tolerability of AVANZ Olive immunotherapy

ALK-Abelló, S.A.0 个研究点目标入组 0 人开始时间: 2011年12月23日最近更新: 2022年4月19日

适应症

试验速览

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•1.Male and female patients 18-65 years of age.
•2.A clinical history of olive pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
•3.Positive SPT to olive pollen (wheal diameter ? 3 mm).
•4.A positive specific IgE against olive pollen (?Class 2; ?0.70 KU/L) documented in the last 5 years
•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 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment.
•2.Uncontrolled or severe asthma.
•3.A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen to which the subject is regularly exposed and sensitized.
•4.History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
•5.At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
•6.Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE, angiotensin converting enzyme inhibitors, tricyclic antidepressants, ?-blockers, mono amine oxidase inhibitors and any other drug containing alum taken on a daily basis.
•7.Previous treatment by other allergen concomitant IT or immunotherapy with Olea europaea extracts within the previous 5 years
•8.History of anaphylactic shock or of severe and recurrent angioedema.

发起方

ALK-Abelló, S.A.