A Randomised, Double-Blind, Parallel Group, Multicentre Study to Assess the Efficacy and Safety of Four Concentrations of Depigoid® Phleum versus Placebo in Patients with Allergic Rhinitis and/or Rhinoconjunctivitis with or without Intermittent Asthma

ETI Pharma GmbH0 个研究点目标入组 200 人开始时间: 2015年3月24日最近更新: 2016年8月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 200

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•A patient must meet ALL the following inclusion criteria to be considered for admission to the study:
•1. Has provided appropriately signed and dated informed consent.
•2. Is a male or female aged = 18 years and = 70 years at Visit S1.
•3. Has a perception of disease activity of at least 2 on a 4-point Likert scale(moderate or severe).
•4. Has a FEV1 value of > 80% of predicted normal at Visit S2.
•5. Has complained about allergic rhinitis and/or rhino-conjunctivitis symptoms for at least 2 years, with or without intermittent asthma symptoms, caused by clinical sensitisation against grass pollen. The immunoglobulin E (IgE)-mediated sensitisation has to be verified by:
•- suggestive medical history AND
•- specific IgE against grass pollen using an ImmunoCAP specific IgE radioallergosorbent test (CAP-RAST) = 2 AND
•- positive skin prick test (SPT).
•An SPT will be considered positive if the test results in a wheal diameter that is at least 3 mm. The wheal for negative control must be < 2 mm.
•6. Total Nasal Symptom Score (TNSS) of = 6 of maximum 12 points at least once during screening exposure of the patient to the allergen in the environmental challenge chamber (ECC)
•7. Patients with allergic co-sensitization are allowed to enter the study:
•- being asymptomatic against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory]),
•- with specific IgE CAP-RAST and SPT co-allergen, as specified below:
•birch (and for Spanish patients only: olive/wall pellitory) pollen: specific IgE CAP-RAST = 2 and < grass and an SPT wheal diameter < grass
•other pollen co-allergen: specific IgE CAP-RAST and an SPT wheal diameter co-allergen < grass,
•house dust mites: specific IgE CAP-RAST = grass and an SPT wheal diameter co-allergen = grass,
•animal dander, only if exposed to animal: specific IgE CAP-RAST animal = grass and an SPT wheal diameter co-allergen = grass, (for patients who are not exposed, no CAP-RAST limit will be applied).
•Note: Alternatively, a currently performed (up to 1 month prior to Screening 2) negative provocation test (conjunctival or nasal) is acceptable and overrules a high CAP-RAST and/or a high SPT result for the respective co-allergen.
•8. If a female is of non-childbearing potential, the patient must be postmenopausal for at least 1 year or surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
•9. If a female is of childbearing potential, the patient must be non-lactating and non-pregnant (with a negative pregnancy test at Visit S2) and must correctly use an effective method of contraception during the study. An effective method of contraception is defined as one that results in a failure rate of less than 1% per year. The following are allowed methods of contraception when used continuously and properly: hormonal contraceptives administered by implant, by injection, or orally; complete abstinence; partner’s vasectomy if the female has not more than one partner. Barrier methods (e.g., preservatives) are only considered effective if used together with one of the above.
•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 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

排除标准

•A patient will NOT be eligible for inclusion in this study if ANY of the following criteria are met:
•1. Acute or chronic infectious conjunctivitis.
•2. Has a history of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial allergens (e.g., house dust mites).
•Patients are not allowed to enter into the study:
•- with typical symptoms against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory], Spanish patients only),
•- with CAP-RAST co-allergen = grass, except for animal dander if not exposed to animal.
•3. Has uncontrolled / partly controlled asthma, according to Global Initiative for Asthma (GINA) Guidelines.
•4. Has acute or chronic inflammatory or infectious diseases of the airways, sinuses or the conjunctiva.
•5. Presence of clinically significant nasalnasal polyps
•6. Anatomical deviations of the nasal Septum that significantly impair ventilation/airflow
•7. Has chronic structural diseases of the lung (e.g., emphysema or bronchiectasis).
•8. Has an autoimmune and/or immune deficiency.
•9. Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
•10. Has a severe uncontrolled disease that could increase the risk of the patients participating in the study, which include, but are not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders.
•11. Has had active malignant disease during the previous 5 years.
•12. Has a significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient.
•13. Has abused alcohol, drugs or medications within the past year.
•14. Has a severe psychiatric, psychological or neurological disorder.
•15. Has used immunotherapy against grass pollen within the last 5 years.
•16. Has used systemic and/or topical treatment with ß blockers within 1 week prior to Visit T1.
•17. Is using any medication that may interfere with the immune system or has been using any medication which might still have an influence on the immune system at Visit S1.
•18. Has used tricyclic antidepressants or monoamine oxidase inhibitors within 1 week prior to Visit S3.
•19. Has used systemic corticosteroids within 3 months prior to Visit S3.
•20. Has been immunised with any vaccine within 7 days prior to Visit T1.
•21. Is expected to be non-compliant and/or not co-operative.
•22. Has participated in another clinical study within 30 days prior to Visit T1.
•23. Has already participated in this study.
•24. Is an employee at the investigational centre or first degree relative or partner of the investigator.
•25. Plans to donate germ cells, blood, organs or bone marrow during the course of the study.
•26. Is not contractually capable.
•27. Has a positive pregnancy test at Visit S2.
•28. Is jurisdictionally or governmentally institutionalised

研究者

发起方

ETI Pharma GmbH

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